{"id":12593,"date":"2018-07-19T01:00:00","date_gmt":"2018-07-30T04:10:59","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/30\/pda%e5%8f%91%e5%b8%83%e3%80%8a%e6%95%b0%e6%8d%ae%e5%ae%8c%e6%95%b4%e6%80%a7%e6%a3%80%e6%9f%a5%e5%ba%94%e5%af%b9%e6%8c%87%e5%8d%97%e3%80%8b\/"},"modified":"2018-07-30T12:11:00","modified_gmt":"2018-07-30T04:11:00","slug":"pda%e5%8f%91%e5%b8%83%e3%80%8a%e6%95%b0%e6%8d%ae%e5%ae%8c%e6%95%b4%e6%80%a7%e6%a3%80%e6%9f%a5%e5%ba%94%e5%af%b9%e6%8c%87%e5%8d%97%e3%80%8b","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/12593\/","title":{"rendered":"PDA\u53d1\u5e03\u300a\u6570\u636e\u5b8c\u6574\u6027\u68c0\u67e5\u5e94\u5bf9\u6307\u5357\u300b"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section>\n<section class=\"cps_inner cps_inner_list js_list_container js_product_container cps_inner_book\">\n<div class=\"cps_inner_wrp js_product_loop_content\"        >\n<div class=\"cps_inner_content\">\n<figure class=\"cps_inner_image_container\">                                                        <\/figure>\n<div class=\"cps_inner_info\">\n<div class=\"cps_inner_info_hd\">\n<h2 class=\"cps_inner_info_title\">2018\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7528\u4e662018\u897f\u836f \u56fd\u5bb6\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u540c\u6b65\u9898\u5e93 \u836f\u5b66\u4e13\u4e1a\u77e5\u8bc6\uff08\u4e8c\uff09\uff08\u7b2c\u4e8c\u7248\uff09<\/h2>\n<p class=\"cps_inner_info_desc\">\u4f5c\u8005\uff1a\u56fd\u5bb6\u6267\u4e1a\u836f\u5e08\u8d44\u683c\u8003\u8bd5\u7814\u7a76\u7ec4<\/p>\n<\/p><\/div>\n<div class=\"cps_inner_info_ft\">\n<div class=\"cps_inner_info_ft_left\">                                      <span class=\"cps_inner_info_from\">                                          <span   style=\"background: url(http:\/\/mmbiz.qpic.cn\/mmbiz_png\/6nVmK0mHaRr8fd8C4yNUm5BrcwmJ17I867w7sZwrxtAmG0NdTKhZj8eAEeRt0Ycgc9pnL4ib77PJ0UKDoT43MsA\/0) no-repeat center;                                          background-size: contain;\" class=\"cps_inner_ic_from\"><\/span>\u5f53\u5f53                                      <\/span>  \t\t\t\t\t\t\t\t\t                                    <span class=\"cps_inner_info_adTag js_cps_adTag\">\u5e7f\u544a<\/span>  \t\t\t\t\t\t\t\t\t                                <\/div>\n<p>                                  <span class=\"cps_inner_btn_cps_info\"><i class=\"cps_inner_ic_miniapp\"><\/i><span class='js_btn_word'>\u8d2d\u4e70<\/span><\/span>                              <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n<section>\n<section class=\"cps_inner cps_inner_list js_list_container js_product_container cps_inner_book\">\n<div class=\"cps_inner_wrp js_product_loop_content\"        >\n<div class=\"cps_inner_content\">\n<figure class=\"cps_inner_image_container\">                                                        <\/figure>\n<div class=\"cps_inner_info\">\n<div class=\"cps_inner_info_hd\">\n<h2 class=\"cps_inner_info_title\">\u8272\u8c31\u5206\u6790(\u738b\u4f1f)(\u53cc\u8bed\u7248)<\/h2>\n<p class=\"cps_inner_info_desc\">\u4f5c\u8005\uff1a\u738b\u4f1f \u4e3b\u7f16  \u5f90\u52a0\u5e94\uff0c\u9a86\u7231\u5170 \u526f\u4e3b\u7f16<\/p>\n<\/p><\/div>\n<div class=\"cps_inner_info_ft\">\n<div class=\"cps_inner_info_ft_left\">                                      <span class=\"cps_inner_info_from\">                                          <span   style=\"background: url(http:\/\/mmbiz.qpic.cn\/mmbiz_png\/6nVmK0mHaRr8fd8C4yNUm5BrcwmJ17I867w7sZwrxtAmG0NdTKhZj8eAEeRt0Ycgc9pnL4ib77PJ0UKDoT43MsA\/0) no-repeat center;                                          background-size: contain;\" class=\"cps_inner_ic_from\"><\/span>\u5f53\u5f53                                      <\/span>  \t\t\t\t\t\t\t\t\t                                    <span class=\"cps_inner_info_adTag js_cps_adTag\">\u5e7f\u544a<\/span>  \t\t\t\t\t\t\t\t\t                                <\/div>\n<p>                                  <span class=\"cps_inner_btn_cps_info\"><i class=\"cps_inner_ic_miniapp\"><\/i><span class='js_btn_word'>\u8d2d\u4e70<\/span><\/span>                              <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<p>                              <br  \/><\/section>\n<section class=\"Powered-by-XIUMI V5\" style=\"background-color: transparent;color: rgb(0, 0, 0);\" >\n<section style=\"margin-bottom: 0px;margin-left: 0px;margin-right: 0px;margin-top: 0px;padding-bottom: 0px;padding-left: 0px;padding-right: 0px;padding-top: 0px;\">\n<section style=\"margin-bottom: 0px;margin-left: 0px;margin-right: 0px;margin-top: 0px;padding-bottom: 0px;padding-left: 0px;padding-right: 0px;padding-top: 0px;\">\n<section style=\"background-color: rgb(255, 255, 255);box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"box-sizing: border-box;margin-bottom: 5px;margin-left: 0px;margin-right: 0px;margin-top: 5px;max-width: 558px;padding-bottom: 0px;padding-left: 0px;padding-right: 0px;padding-top: 0px;word-wrap: break-word;\">\n<section style=\"border-bottom-color: rgb(255, 255, 255);border-bottom-left-radius: 50%;border-bottom-right-radius: 50%;border-bottom-style: solid;border-bottom-width: 5px;border-left-color: rgb(255, 255, 255);border-left-style: solid;border-left-width: 5px;border-right-color: rgb(255, 255, 255);border-right-style: solid;border-right-width: 5px;border-top-color: rgb(255, 255, 255);border-top-left-radius: 50%;border-top-right-radius: 50%;border-top-style: solid;border-top-width: 5px;box-sizing: border-box;height: 80px;margin-bottom: 0px;margin-left: 0px;margin-right: 0px;margin-top: 15px;max-width: 558px;padding-bottom: 0px;padding-left: 0px;padding-right: 0px;padding-top: 0px;transform: matrix(1, 0, 0, 1, 0, 0);width: 80px;word-wrap: break-word;\"><img style=\"border-bottom-left-radius: 50%;border-bottom-right-radius: 50%;border-top-left-radius: 50%;border-top-right-radius: 50%;box-sizing: border-box;height: 70px;margin-bottom: 0px;margin-left: 0px;margin-right: 0px;margin-top: 0px;max-width: 70px;padding-bottom: 0px;padding-left: 0px;padding-right: 0px;padding-top: 0px;visibility: visible;width: 70px;word-wrap: break-word;\"          src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/07\/beepress1-1532923859.jpeg\" alt=\"PDA\u53d1\u5e03\u300a\u6570\u636e\u5b8c\u6574\u6027\u68c0\u67e5\u5e94\u5bf9\u6307\u5357\u300b\" title=\"PDA\u53d1\u5e03\u300a\u6570\u636e\u5b8c\u6574\u6027\u68c0\u67e5\u5e94\u5bf9\u6307\u5357\u300b\"  \/><\/section>\n<section style=\"box-sizing: border-box;margin-bottom: 0px;margin-left: 0px;margin-right: 0px;margin-top: -90px;max-width: 558px;padding-bottom: 0px;padding-left: 50px;padding-right: 0px;padding-top: 0px;word-wrap: break-word;\">\n<section style=\"background-color: rgb(230, 230, 230);box-sizing: border-box;margin-bottom: 0px;margin-left: 0px;margin-right: 0px;margin-top: 0px;max-width: 508px;padding-bottom: 10px;padding-left: 40px;padding-right: 10px;padding-top: 10px;word-wrap: break-word;\">\n<p style=\"box-sizing: border-box;clear: both;font-size: 14px;margin-bottom: 0px;margin-left: 0px;margin-right: 0px;margin-top: 0px;max-width: 458px;min-height: 14px;padding-bottom: 0px;padding-left: 0px;padding-right: 0px;padding-top: 0px;word-wrap: break-word;\"><span style=\"box-sizing: border-box;color: rgb(62, 62, 62);font-size: 12px;letter-spacing: 1px;margin-bottom: 0px;margin-left: 0px;margin-right: 0px;margin-top: 0px;max-width: 100%;padding-bottom: 0px;padding-left: 0px;padding-right: 0px;padding-top: 0px;text-align: justify;word-wrap: break-word;\">\u5916\u8d44\u5927\u578b\u5236\u836f\u516c\u53f8\u6280\u672f\u3001\u7814\u53d1\u3001\u8d28\u91cf\u603b\u76d1\uff0c\u9a8c\u8bc1\u7ba1\u7406\u8d44\u6df1\u4e13\u5bb6\uff0c\u591a\u5bb6\u5236\u836f\u516c\u53f8\u987e\u95ee\uff0c\u836f\u5b66\u7855\u58eb\u3002<span style=\"margin: 0px;padding: 0px;color: rgb(62, 62, 62);\">\u56fd\u5bb6\u5de5\u827a\u6838\u5bf9\u672a\u96e8\u7ef8\u7f2a\u4e4b\u9645\uff0c\u6210\u529f\u89e3\u51b3\u4e86\u591a\u5bb6\u5728\u4ea7\u4ea7\u54c1\u5904\u65b9\u3001\u5de5\u827a\u95ee\u9898\u3002\u5904\u65b9\u5de5\u827a\u7684\u4e8c\u6b21\u5f00\u53d1\uff0c\u514d\u8d39\u54a8\u8be2\uff0c\u5168\u7a0b\u4fdd\u5bc6\u3002\u90ae\u7bb1\uff1a1193686015@qq.com\u3002<\/span><\/span><br  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section  >\n<section >\n<section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;line-height: 27.2000007629395px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);\" >\n<section style=\"margin: 10px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: center;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;vertical-align: middle;display: inline-block;overflow: hidden !important;\"><img style=\"margin: 0px;padding: 0px;height: auto !important;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;vertical-align: middle;width: auto !important;visibility: visible !important;\"     src=\"https:\/\/mmbiz.qpic.cn\/mmbiz_png\/ZzVJoRDNConNKaKSiaUbajcibmNHJptOXUMCkx8nICDUT5x1bwuEtatlzZRsbibVbsxuiaFpMscntvCyiaP1PFibxcyw\/640?wx_fmt=pnghigh\"  \/><\/section>\n<\/section>\n<\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;line-height: 27.2000007629395px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;letter-spacing: 0px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\">PDA\u5728\u51762018\u5e745\u6708\/ 6\u6708PDA \u5236\u836f\u79d1\u5b66\u4e0e\u6280\u672f\u671f\u520a\u4e0a\u53d1\u8868\u4e86\u9898\u4e3a\u300a<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><span style=\"margin: 0px;padding: 0px;letter-spacing: 0px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\">PDA \u8ba8\u8bba\u8981\u70b9\uff1a\u6587\u6863\/\u6570\u636e\u7ba1\u7406\u4e0e\u63a7\u5236\u4ee5\u53ca\u6570\u636e\u53ef\u9760\u6027\u4e3a\u51c6\u5907\u68c0\u67e5\u7684\u6700\u4f73\u5b9e\u8df5<\/span>\uff08PDA Points to Consider: Best Practices for Document\/Data Management and Control and Preparing for Data Integrity Inspections\uff09<\/span><span style=\"margin: 0px;padding: 0px;letter-spacing: 0px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u300b\u7684\u6587\u7ae0\uff0c\u8be5\u6587\u7ae0\u5305\u62ec\u5bf911\u4e2a\u6570\u636e\u5b8c\u6574\u6027\u76f8\u5173\u7684\u95ee\u9898\u7684\u89e3\u7b54\uff0c\u5982\u4e0b\uff1a<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Question 1: Copies of GMP Records<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7591\u95ee1\uff1aGMP\u8bb0\u5f55\u7684\u62f7\u8d1d<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Context:&nbsp;<\/strong>On a daily basis, there are many valid reasons why a firm may wish to make copies of GMP records, including records that contain a lot number, batch-specific data, test results, or other data. For example, firms may make a copy of a batch record to provide to a Technical Services group to conduct an investigation. Especially in light of recent 483 observations that highlight documents with batch information found in a shredder, it is unclear under what conditions it is permissible to treat copies of GMP records as uncontrolled, non-GMP records. Requiring that the issuance, management, and destruction of all of these documents be controlled by the Quality Unit imposes an unnecessary burden on industry. The key is for firms to be able to show how they assure that an original record is the original record and that the data in the record satisfy ALCOA principles.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u80cc\u666f\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5728\u65e5\u5e38\u7684\u5de5\u4f5c\u4e2d\uff0c\u516c\u53f8\u6709\u5f88\u591a\u6b63\u5f53\u7406\u7531\u89e3\u91ca\u4e3a\u4ec0\u4e48\u4ed6\u4eec\u9700\u8981\u62f7\u8d1dGMP\u8bb0\u5f55\u3002\u8fd9\u4e9b\u8bb0\u5f55\u4e2d\u6709\u6279\u53f7\u3001\u6279\u6570\u636e\u3001\u6d4b\u8bd5\u7ed3\u679c\u6216\u5176\u4ed6\u6570\u636e\u3002\u4f8b\u5982\uff0c\u516c\u53f8\u4e3a\u6280\u672f\u670d\u52a1\u56e2\u961f\u63d0\u4f9b\u4e00\u4efd\u6279\u8bb0\u5f55\u7684\u626b\u63cf\u4ef6\u4ee5\u4f9b\u4ed6\u4eec\u8fdb\u884c\u8c03\u67e5\u3002\u7279\u522b\u662f\u6700\u8fd1\u7684483\u7f3a\u9677\u4fe1\u4e2d\uff0c\u5728\u788e\u7eb8\u673a\u4e2d\u53d1\u73b0\u4e86\u5305\u542b\u6279\u6b21\u4fe1\u606f\u7684\u6587\u4ef6\u95ee\u9898\u8f83\u4e3a\u7a81\u51fa\uff0c\u5728\u4f55\u79cd\u6761\u4ef6\u4e0b\u6309\u7167\u975e\u53d7\u63a7\u3001\u975eGMP\u8bb0\u5f55\u7684\u65b9\u5f0f\u6765\u5904\u7406\u8fd9\u4e9bGMP\u590d\u5370\u4ef6\u7684\u62f7\u8d1d\u5e76\u4e0d\u6e05\u695a\u3002\u5982\u8981\u6c42\u8fd9\u4e9b\u6587\u4ef6\u7531\u8d28\u91cf\u90e8\u53d1\u653e\u3001\u7ba1\u7406\u548c\u9500\u6bc1\u5219\u5bf9\u884c\u4e1a\u5f3a\u52a0\u8d1f\u62c5\u3002\u5173\u952e\u662f\u516c\u53f8\u8981\u80fd\u591f\u8bc1\u660e\u4ed6\u4eec\u5982\u4f55\u80fd\u4fdd\u8bc1\u539f\u59cb\u8bb0\u5f55\u5c31\u662f\u539f\u59cb\u5f97\u8bb0\u5f55\u5e76\u4e14\u8bb0\u5f55\u4e2d\u7684\u6570\u636e\u7b26\u5408ALCOA\u539f\u5219\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Issue:&nbsp;<\/strong>Is a copy of a GMP record (e.g. printout of the raw data or photocopy\/scan of a paper original record) itself considered a GMP document?<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u95ee\u9898\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u53ef\u4ee5\u8ba4\u4e3aGMP\u62f7\u8d1d\u4ef6\uff08\u4f8b\u5982\u539f\u59cb\u6570\u636e\u7684\u6253\u5370\u4ef6\u6216\u4e00\u4efd\u7eb8\u8d28\u539f\u59cb\u8bb0\u5f55\u7684\u7167\u7247\/\u626b\u63cf\u4ef6\uff09\u672c\u8eab\u5c31\u662fGMP\u6587\u4ef6\u5417\uff1f<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\">Clarification: As long as firms have full control over original GMP documents and the original GMP document is retained as required by the firm\u2019s procedure, copies can be created and destroyed as needed. A copy of a GMP record need only be retained if additional GMP information (e.g., raw data) is recorded on the document copy. As a part of maintaining control over GMP records, it is advisable to make sure that copies can be readily distinguished from originals (e.g., copies are stamped as \u201ccopy\u201d and\/or originals are stamped as \u201coriginal\u201d).<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u89e3\u91ca<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\uff1a\u53ea\u8981\u516c\u53f8\u5bf9\u539f\u59cbGMP\u6587\u4ef6\u6709\u5b8c\u5168\u7684\u63a7\u5236\u6743\u4e14\u539f\u59cbGMP\u6587\u4ef6\u6309\u7167\u516c\u53f8\u65e2\u5b9a\u7684\u5236\u5ea6\u8fdb\u884c\u4fdd\u5b58\uff0c\u90a3\u4e48\u5c31\u53ef\u4ee5\u6309\u9700\u5236\u4f5c\u6216\u9500\u6bc1\u62f7\u8d1d\u4ef6\u3002\u53ea\u6709\u5728GMP\u6587\u4ef6\u7684\u62f7\u8d1d\u4ef6\u4e0a\u8bb0\u5f55\u4e86\u989d\u5916\u7684GMP\u4fe1\u606f\uff08\u4f8b\u5982\u539f\u59cb\u6570\u636e\uff09\uff0c\u90a3\u4e48\u8fd9\u79cd\u62f7\u8d1d\u4ef6\u624d\u9700\u8981\u4fdd\u5b58\u3002\u4f5c\u4e3a\u5bf9GMP\u8bb0\u5f55\u7ef4\u6301\u63a7\u5236\u7684\u4e00\u90e8\u5206\uff0c\u6700\u597d\u786e\u4fdd\u62f7\u8d1d\u4ef6\u53ef\u4ee5\u975e\u5e38\u5bb9\u6613\u548c\u539f\u4ef6\u533a\u5206\u5f00\u6765\uff08\u4f8b\u5982\u5728\u62f7\u8d1d\u4ef6\u4e0a\u5370\u4e0a\u201c\u62f7\u8d1d\u7ae0\u201d\u548c\/\u6216\u5728\u539f\u4ef6\u4e0a\u5370\u4e0a\u201c\u539f\u4ef6\u201d\u7ae0\uff09\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Question 2: Documents not traditionally considered GMP records&nbsp;<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7591\u95ee2\uff1a\u4f20\u7edf\u4e0a\u4e0d\u8ba4\u4e3a\u662fGMP\u6587\u4ef6\u7684\u6587\u4ef6<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Context:&nbsp;<\/strong>In recent 483s, we have observed that documents not traditionally considered GMP records (e.g., e-mails and other communications) become the object of scrutiny and observations. A working definition of what the agency currently views as a GMP record for such things as e-mail, supervisor schedule, etc. would be helpful for industry. Firms communicate informally about production and quality-related activities on a continuing basis in order to facilitate operations. An e-mail regarding batch release may be essentially the written equivalent of a phone call from one colleague to another stating that a batch has been released. Requiring formal controls around all of these documents, or requiring that such documents cannot be printed and discarded\/destroyed\/shredded at will, creates a large burden on firms and their quality units.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u80cc\u666f\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5728\u6700\u8fd1\u7684483\u7f3a\u9677\u4fe1\u4e2d\uff0c\u6211\u4eec\u53d1\u73b0\u4f20\u7edf\u4e0a\u4e0d\u8ba4\u4e3a\u662fGMP\u6587\u4ef6\u7684\u6587\u4ef6\uff08\u4f8b\u5982\u7535\u5b50\u90ae\u4ef6\u548c\u5176\u4ed6\u901a\u8baf\u4ef6\uff09\u6b63\u6210\u4e3a\u68c0\u67e5\u5bf9\u8c61\u5e76\u88ab\u5217\u4e3a\u7f3a\u9677\u9879\u3002\u90a3\u4e48\u5bf9\u5f53\u524d\u76d1\u7ba1\u673a\u6784\u5bf9\u4e8e\u4f55\u79cd\u6587\u4ef6\u5982\u7535\u5b50\u90ae\u4ef6\u3001\u751f\u4ea7\u8ba1\u5212\u7b49\u8ba4\u4e3a\u4e3aGMP\u6587\u4ef6\u5408\u9002\u7684\u5b9a\u4e49\uff0c\u5c06\u4f1a\u5bf9\u884c\u4e1a\u6709\u6240\u5e2e\u52a9\u3002\u516c\u53f8\u7ecf\u5e38\u4e3a\u4fbf\u4e8e\u5de5\u4f5c\u8fdb\u884c\u4e00\u4e9b\u751f\u4ea7\u548c\u8d28\u91cf\u76f8\u5173\u6d3b\u52a8\u7684\u975e\u6b63\u5f0f\u6c9f\u901a\u3002\u4e00\u5c01\u5173\u4e8e\u6279\u653e\u884c\u7684\u90ae\u4ef6\u53ef\u80fd\u672c\u8d28\u4e0a\u76f8\u5f53\u4e8e\u4e00\u540d\u5458\u5de5\u6253\u7535\u8bdd\u7ed9\u53e6\u5916\u4e00\u540d\u5458\u5de5\u901a\u77e5\u6279\u6b21\u5df2\u653e\u884c\u7684\u4e66\u9762\u8bb0\u5f55\u3002\u5982\u8981\u6c42\u5bf9\u6240\u6709\u8fd9\u4e9b\u6587\u4ef6\u8fdb\u884c\u6b63\u5f0f\u7684\u63a7\u5236\u6216\u8981\u6c42\u8fd9\u4e9b\u6587\u4ef6\u4e0d\u80fd\u88ab\u968f\u610f\u6253\u5370\u548c\u4e22\u5f03\/\u9500\u6bc1\/\u7c89\u788e\uff0c\u5c06\u4f1a\u5bf9\u516c\u53f8\u548c\u4ed6\u4eec\u7684\u8d28\u91cf\u90e8\u95e8\u9020\u6210\u6c89\u91cd\u7684\u8d1f\u62c5\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Issue:<\/strong>&nbsp;Are e-mails or other papers that contain batch-related information such as product name, lot number, or test results considered GMP records if local procedures are clear on what is the system of record?<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u95ee\u9898\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5982\u679c\u516c\u53f8\u6587\u4ef6\u660e\u786e\u89c4\u5b9a\u54ea\u4e9b\u5c5e\u4e8e\u8bb0\u5f55\u7cfb\u7edf\uff0c\u90a3\u4e48\u542b\u6709\u6279\u76f8\u5173\u7684\u4fe1\u606f\uff0c\u5982\u4ea7\u54c1\u540d\u79f0\u3001\u6279\u53f7\u6216\u6d4b\u8bd5\u7ed3\u679c\u7684\u90ae\u4ef6\u6216\u5176\u4ed6\u7eb8\u8d28\u6587\u4ef6\u662f\u5426\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\uff1f<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Clarification:&nbsp;<\/strong>Whether a document is considered a GMP record depends on whether it is generated to satisfy a GMP requirement (see Data Integrity and Compliance with CGMP, Guidance for Industry, April 2016 draft, \u201cWhen generated to satisfy a CGMP requirement, all data become a CGMP record.\u201d) For example, if e-mail is used as a record of batch release, it is a GMP document. If e-mail is used to communicate that a batch has been released, but the system of record for batch release is not e-mail, then the e-mail is not a GMP record. Similarly, drafts of risk assessments, investigation reports, etc. are not cGMP records until they have been reviewed and finalized. If companies use e-mails for GMP purposes, it is advisable to have a controlled process, governed by an SOP.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u89e3\u91ca\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4e00\u4efd\u6587\u4ef6\u662f\u5426\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\uff0c\u53d6\u51b3\u4e8e\u8fd9\u4efd\u6587\u4ef6\u7684\u751f\u6210\u662f\u5426\u7b26\u5408GMP\u8981\u6c42\uff08\u89c1\u6570\u636e\u53ef\u9760\u6027\u548ccGMP\u5408\u89c4\u6027\u884c\u4e1a\u6307\u5357\uff0c2016\u5e744\u6708\u8349\u6848\uff0c\u201c\u5f53\u6240\u6709\u6570\u636e\u7684\u751f\u6210\u6ee1\u8db3GMP\u8981\u6c42\u65f6\uff0c\u90a3\u4e48\u8be5\u8bb0\u5f55\u5c31\u662fcGMP\u8bb0\u5f55\u201d\uff09\u3002\u4f8b\u5982\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u4f5c\u4e3a\u6279\u653e\u884c\u7684\u8bb0\u5f55\uff0c\u90a3\u4e48\u5b83\u5c31\u662fGMP\u8bb0\u5f55\u3002\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u53ea\u662f\u7528\u6765\u901a\u77e5\u6279\u5df2\u653e\u884c\u5e76\u4e14\u6279\u653e\u884c\u7684\u8bb0\u5f55\u7cfb\u7edf\u5e76\u4e0d\u662f\u7535\u5b50\u90ae\u4ef6\uff0c\u90a3\u4e48\u8fd9\u4e2a\u7535\u5b50\u90ae\u4ef6\u5c31\u4e0d\u662fGMP\u8bb0\u5f55\u3002\u7c7b\u4f3c\u7684\uff0c\u8349\u7a3f\u7248\u98ce\u9669\u8bc4\u4f30\u548c\u8c03\u67e5\u62a5\u544a\u7b49\u3002\u8fd9\u4e9b\u8bb0\u5f55\u90fd\u4e0d\u662fGMP\u8bb0\u5f55\uff0c\u9664\u975e\u7ecf\u8fc7\u5ba1\u6838\u548c\u5b9a\u7a3f\u3002\u5982\u679c\u516c\u53f8\u5c06\u7535\u5b50\u90ae\u4ef6\u7528\u4e8eGMP\u7528\u9014\uff0c\u6700\u597d\u6709\u76f8\u5e94\u7684\u63a7\u5236\u7a0b\u5e8f\uff0c\u901a\u8fc7SOP\u6765\u7ba1\u7406\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Question 3: Personal Diaries&nbsp;<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7591\u95ee3\uff1a\u79c1\u4eba\u7b14\u8bb0<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Context:<\/strong>&nbsp;It is common for employees to use personal diaries or paper to record notes for themselves for non-GMP purposes e.g. to-do list, training notes, personnel information. These notes are not considered to be GMP records by industry in general. Turning these notes into GMP records may in fact deter individuals from writing down information that is useful for effective time management or reinforcing one\u2019s own learning.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u80cc\u666f\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5458\u5de5\u7528\u79c1\u4eba\u7b14\u8bb0\u6216\u8005\u7eb8\u5f20\u6765\u8bb0\u5f55\u4e00\u4e9b\u975eGMP\u7684\u4e1c\u897f\uff0c\u4f8b\u5982\u5de5\u4f5c\u5b89\u6392\u3001\u57f9\u8bad\u6ce8\u91ca\u3001\u4eba\u5458\u4fe1\u606f\u7b49\u3002\u8fd9\u4e9b\u8bb0\u5f55\u901a\u5e38\u5728\u884c\u4e1a\u5185\u4e0d\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\u3002\u5982\u679c\u8981\u6c42\u5c06\u8fd9\u4e9b\u8bb0\u5f55\u8f6c\u4e3aGMP\u8bb0\u5f55\u4e8b\u5b9e\u4e0a\u53cd\u800c\u53ef\u80fd\u4f1a\u59a8\u788d\u4ed6\u4eec\u5199\u4e0b\u5bf9\u65f6\u95f4\u6709\u6548\u7ba1\u7406\u6216\u52a0\u5f3a\u81ea\u8eab\u5b66\u4e60\u6709\u7528\u7684\u4fe1\u606f\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Issue:&nbsp;<\/strong>What types of entries\/information can be recorded in a personal diary without it being considered GMP record?<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u95ee\u9898\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4f55\u79cd\u6761\u76ee\/\u4fe1\u606f\u53ef\u4ee5\u8bb0\u5f55\u5230\u79c1\u4eba\u7b14\u8bb0\u4e2d\u5e76\u4e14\u4e0d\u4f1a\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\uff1f<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Clarification:&nbsp;<\/strong>If notes and diaries are used as personal and informal means of recording and are not the system of record for execution or documentation of GMP activities, then they are not considered to be GMP records. These informal recordings in personal notebooks might include to-do lists, training notes, coaching ideas, personnel information, etc.). Firms may want to consider controlling and spot checking personal notebooks to ensure that they are being used only for non-GMP information. Firms may also want to train employees on what is and is not proper for recording in personal notebooks.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u89e3\u91ca\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5982\u679c\u6ce8\u91ca\u548c\u7b14\u8bb0\u7528\u4e8e\u79c1\u4eba\u4ee5\u53ca\u975e\u6b63\u5f0f\u7684\u8bb0\u5f55\uff0c\u5e76\u4e14\u4e0d\u5c5e\u4e8e\u6267\u884c\u6216\u8bb0\u5f55GMP\u6d3b\u52a8\u8bb0\u5f55\u7cfb\u7edf\uff0c\u90a3\u4e48\u5b83\u4eec\u5c31\u4e0d\u4f1a\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\u3002\u8fd9\u4e9b\u8bb0\u5f55\u5728\u79c1\u4eba\u7b14\u8bb0\u672c\u4e0a\u7684\u975e\u6b63\u5f0f\u7684\u8bb0\u5f55\u53ef\u80fd\u5305\u62ec\u5de5\u4f5c\u8ba1\u5212\u3001\u57f9\u8bad\u6ce8\u91ca\u3001\u6267\u6559\u601d\u60f3\u3001\u4e2a\u4eba\u4fe1\u606f\u7b49\u3002\u516c\u53f8\u53ef\u4ee5\u8003\u8651\u63a7\u5236\u548c\u62bd\u67e5\u8fd9\u4e9b\u79c1\u4eba\u7b14\u8bb0\u672c\u4ee5\u4fdd\u8bc1\u5b83\u4eec\u7684\u786e\u53ea\u88ab\u7528\u4e8e\u975eGMP\u7528\u9014\u3002\u516c\u53f8\u540c\u6837\u53ef\u4ee5\u57f9\u8bad\u5458\u5de5\u5173\u4e8e\u4ec0\u4e48\u53ef\u4ee5\u4ee5\u53ca\u4ec0\u4e48\u4e0d\u9002\u5408\u8bb0\u5f55\u5728\u79c1\u4eba\u7b14\u8bb0\u672c\u4e0a\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Question 4: Drafts of GMP documents \u7591\u95ee4\uff1a<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">GMP\u6587\u6863\u7684\u8349\u7a3f\u4ef6<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Context:&nbsp;<\/strong>Firms generate many drafts of CGMP documents. It would be onerous and confusing to require that all of those documents be retained.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u80cc\u666f\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u516c\u53f8\u4f1a\u4ea7\u751f\u5f88\u591acGMP\u6587\u6863\u7684\u8349\u7a3f\u4ef6\u3002\u4ee4\u4eba\u611f\u5230\u8ff7\u60d1\u7684\u662f\u8fd9\u4e9b\u6587\u6863\u662f\u5426\u90fd\u9700\u8981\u5b58\u6863\uff0c\u5982\u679c\u662f\u7684\u8bdd\u5de5\u4f5c\u91cf\u4f1a\u975e\u5e38\u7e41\u91cd\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Issue:&nbsp;<\/strong>Are firms required to retain drafts of CGMP documents, such as reports of risk assessments, investigations, and validation?<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u95ee\u9898\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">GMP\u6587\u6863\u7684\u8349\u7a3f\u4ef6\u662f\u5426\u9700\u8981\u5b58\u6863\uff0c\u4f8b\u5982\u98ce\u9669\u8bc4\u4f30\u62a5\u544a\u3001\u8c03\u67e5\u62a5\u544a\u4ee5\u53ca\u9a8c\u8bc1\u62a5\u544a\uff1f<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Clarification:<\/strong>&nbsp;Once a final GMP document of record is created, drafts and documents used in the creation of the document of record no longer need to be retained. This includes documents and drafts used or created in the course of conducting an investigation. The final document is the document of record. GMP Change Control processes come into effect once a GMP document is formally approved. As a part of maintaining control over GMP documents, it is advisable to make sure that drafts can be readily distinguished from final documents (e.g., they are stamped as \u201cdraft\u201d).<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u89e3\u91ca\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4e00\u65e6\u6700\u7ec8\u7684GMP\u6587\u6863\u8bb0\u5f55\u5b9a\u7a3f\uff0c\u8fd9\u4e9b\u6587\u6863\u5b9a\u7a3f\u8fc7\u7a0b\u4e2d\u7684\u8349\u7a3f\u4ef6\u548c\u6587\u6863\u5c31\u4e0d\u5728\u9700\u8981\u7559\u5b58\uff0c\u5305\u62ec\u8c03\u67e5\u8fc7\u7a0b\u4e2d\u4f7f\u7528\u6216\u4ea7\u751f\u7684\u8349\u7a3f\u4ef6\u548c\u6587\u6863\u3002\u5b9a\u7a3f\u7684\u6587\u6863\u5219\u662f\u6b63\u5f0f\u7684\u8bb0\u5f55\u3002\u5f53\u4e00\u4efdGMP\u6587\u6863\u5f97\u5230\u6b63\u5f0f\u6279\u51c6\u540e\uff0cGMP\u53d8\u66f4\u63a7\u5236\u7a0b\u5e8f\u5373\u5f00\u59cb\u751f\u6548\u3002\u4f5c\u4e3aGMP\u6587\u6863\u7ef4\u6301\u63a7\u5236\u7684\u4e00\u90e8\u5206\uff0c\u6700\u597d\u786e\u4fdd\u90a3\u4e9b\u8349\u7a3f\u4ef6\u53ef\u4ee5\u548c\u6700\u7ec8\u7684\u6587\u6863\u6613\u4e8e\u533a\u5206\uff08\u4f8b\u5982\u5728\u8349\u7a3f\u4ef6\u4e0a\u76d6\u4e0a\u201c\u8349\u7a3f\u201d\u7ae0\uff09\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Question 5: Emails as GMP records&nbsp;<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7591\u95ee5\uff1a\u90ae\u4ef6\u4f5c\u4e3aGMP\u8bb0\u5f55<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Context:&nbsp;<\/strong>Firms use e-mail for a variety of GMP and non-GMP purposes. It is unclear to many firms which uses constitute GMP uses and whether a firm\u2019s entire e-mail system becomes a GMP system due to its use.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u80cc\u666f\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u516c\u53f8\u901a\u5e38\u90fd\u4f1a\u5728GMP\u548c\u975eGMP\u7684\u6d3b\u52a8\u4e2d\u4f7f\u7528\u7535\u5b50\u90ae\u4ef6\u3002\u8bb8\u591a\u516c\u53f8\u90fd\u4e0d\u6e05\u695a\u54ea\u4e9b\u7528\u9014\u5c5e\u4e8eGMP\u7528\u9014\u4ee5\u53ca\u516c\u53f8\u662f\u5426\u56e0\u9700\u8981\u4e3a\u7535\u5b50\u90ae\u4ef6\u7684\u7528\u9014\u800c\u5c06\u6574\u4e2a\u7535\u5b50\u90ae\u4ef6\u7cfb\u7edf\u53d8\u6210GMP\u7cfb\u7edf\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Issue:&nbsp;<\/strong>Are e-mails considered to be GMP records?<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u95ee\u9898\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7535\u5b50\u90ae\u4ef6\u662f\u5426\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\uff1f<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Clarification:&nbsp;<\/strong>Whether e-mails are GMP records depends on whether they are being used to communicate GMP actions or content or capture GMP decision-making. For example, if e-mail is used as the system of record for batch release, then those e-mails are GMP records, and local procedures should be clear on what is the system of record. If e-mail is used to communicate that a batch has been dispositioned, but that decision is formally captured elsewhere in accordance with the firm\u2019s SOPs, then the e-mail is not a GMP record. Similarly, if e-mail is used as the official system for escalation of quality issues per a firm\u2019s SOPs, then those e-mails are GMP records. If e-mail is used for informational purposes to note that there has been an escalation, and there is a separate system of record for escalations, then the e-mail is not a GMP record. The use of e-mail in GMP process(es) should be well-described in the&nbsp;<span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">relevant SOP(s).&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u89e3\u91ca\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7535\u5b50\u90ae\u4ef6\u662f\u5426\u662fGMP\u8bb0\u5f55\u53d6\u51b3\u4e8e\u4ed6\u4eec\u662f\u5426\u662f\u7528\u4e8eGMP\u6d3b\u52a8\u6216\u5185\u5bb9\u7684\u6c9f\u901a\u8fd8\u662f\u7528\u4e8e\u8bb0\u5f55GMP\u51b3\u7b56\u3002\u4f8b\u5982\uff0c\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u7528\u4e8e\u6279\u653e\u884c\u7684\u8bb0\u5f55\u7cfb\u7edf\uff0c\u90a3\u4e48\u8fd9\u4e9b\u90ae\u4ef6\u5c31\u5c5e\u4e8eGMP\u8bb0\u5f55\u3002\u516c\u53f8\u9700\u8981\u6709\u7a0b\u5e8f\u6e05\u6670\u89c4\u5b9a\u8bb0\u5f55\u7cfb\u7edf\u662f\u4ec0\u4e48\u3002\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u53ea\u662f\u7528\u6765\u901a\u77e5\u4ea7\u54c1\u5df2\u7ecf\u88ab\u5904\u7406\uff0c\u800c\u6b63\u5f0f\u7684\u51b3\u5b9a\u662f\u6309\u7167SOP\u5728\u522b\u5904\u8bb0\u5f55\uff0c\u90a3\u4e48\u8fd9\u79cd\u7535\u5b50\u90ae\u4ef6\u5c31\u4e0d\u662fGMP\u8bb0\u5f55\u3002\u7c7b\u4f3c\u5730\uff0c\u5982\u679c\u6309\u7167\u516c\u53f8SOP\uff0c\u7535\u5b50\u90ae\u4ef6\u4f5c\u4e3a\u8d28\u91cf\u95ee\u9898\u5347\u7ea7\u7684\u6b63\u5f0f\u7cfb\u7edf\uff0c\u90a3\u4e48\u90a3\u4e9b\u7535\u5b50\u90ae\u4ef6\u5c31\u662fGMP\u8bb0\u5f55\u3002\u800c\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u53ea\u662f\u7528\u4e8e\u4fe1\u606f\u53c2\u8003\uff0c\u8bf4\u660e\u4e0b\u53d1\u751f\u4e86\u95ee\u9898\u5347\u7ea7\u5e76\u4e14\u6709\u72ec\u7acb\u7684\u7cfb\u7edf\u6765\u8bb0\u5f55\u8fd9\u6b21\u95ee\u9898\u5347\u7ea7\uff0c\u90a3\u4e48\u8fd9\u79cd\u7535\u5b50\u90ae\u4ef6\u5c31\u4e0d\u5c5e\u4e8eGMP\u8bb0\u5f55\u3002\u7528\u4e8eGMP\u7528\u9014\u7684\u7535\u5b50\u90ae\u4ef6\u9700\u8981\u5728\u76f8\u5173\u7684SOP\u4e2d\u8fdb\u884c\u8be6\u7ec6\u7684\u63cf\u8ff0\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\">To create a GMP record that is separate from the e-mail system, and to avoid an e-mail system being used as a GMP system of record, a firm may wish to consider printing, signing\/initialing, and dating all of the relevant e-mails that constitute a GMP record. All of this should be done in accordance with a written SOP.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4e3a\u5efa\u7acb\u4e00\u4e2a\u72ec\u7acb\u4e8e\u7535\u5b50\u90ae\u4ef6\u7cfb\u7edf\u7684GMP\u8bb0\u5f55\u4ee5\u53ca\u4e3a\u907f\u514d\u7535\u5b50\u90ae\u4ef6\u7cfb\u7edf\u7528\u4e8eGMP\u8bb0\u5f55\u7cfb\u7edf\uff0c\u516c\u53f8\u53ef\u4ee5\u8003\u8651\u5bf9\u6240\u6709GMP\u8bb0\u5f55\u76f8\u5173\u7684\u7535\u5b50\u90ae\u4ef6\u8fdb\u884c\u6253\u5370\u3001\u7b7e\u540d\/\u7b80\u7b7e\u4ee5\u53ca\u7b7e\u65e5\u671f\u3002\u8fd9\u4e9b\u5de5\u4f5c\u90fd\u9700\u8981\u6309\u7167\u4e66\u9762\u7684SOP\u8fdb\u884c\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Question 6: Business records that are not GMP records&nbsp;<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7591\u95ee6\uff1a\u4e0d\u5c5e\u4e8eGMP\u8bb0\u5f55\u7684\u4e1a\u52a1\u8bb0\u5f55<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Context:&nbsp;<\/strong>Recent inspections have delved into business records that are not GMP records, such as footage from security cameras, drafts of GMP documents such as investigations, uncontrolled document copies, and security key card access systems. FDA may choose to inspect these items and may even use them as a means of finding GMP violations. However, the fact that records may be inspected should not mean that these items are GMP records. Otherwise, it would create an enormous burden on the Quality Unit to review and control new kinds of records.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u80cc\u666f\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6700\u8fd1\u7684\u68c0\u67e5\u5f00\u59cb\u5173\u6ce8\u4e0d\u5c5e\u4e8eGMP\u8bb0\u5f55\u7684\u4e1a\u52a1\u8bb0\u5f55\uff0c\u4f8b\u5982\u5b89\u5168\u5f55\u50cf\u5f71\u50cf\u3001GMP\u6587\u4ef6\u8349\u7a3f\uff0c\u4f8b\u5982\u8c03\u67e5\u3001\u975e\u53d7\u63a7\u7684\u6587\u4ef6\u62f7\u8d1d\u4ef6\u4ee5\u53ca\u5b89\u5168\u5bc6\u5319\u5361\u8bbf\u95ee\u7cfb\u7edf\u3002FDA\u53ef\u80fd\u9009\u62e9\u68c0\u67e5\u8fd9\u4e9b\u9879\u76ee\u4e14\u751a\u81f3\u53ef\u80fd\u628a\u4ed6\u4eec\u4f5c\u4e3aGMP\u8fdd\u89c4\u5b9a\u8bba\u7684\u4e00\u79cd\u65b9\u5f0f\u3002\u7136\u800c\uff0c\u5c3d\u7ba1\u8fd9\u4e9b\u8bb0\u5f55\u88ab\u68c0\u67e5\uff0c\u4f46\u5e76\u4e0d\u662f\u610f\u5473\u7740\u5b83\u4eec\u5c5e\u4e8eGMP\u8bb0\u5f55\u3002\u5426\u5219\u8d28\u91cf\u90e8\u95e8\u9700\u8981\u5ba1\u6838\u548c\u63a7\u5236\u8fd9\u4e9b\u8bb0\u5f55\uff0c\u8fd9\u4f1a\u9020\u6210\u5de8\u5927\u7684\u8d1f\u62c5\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Issue:<\/strong>&nbsp;If non-GMP records, such as footage from security cameras, drafts of GMP documents such as investigations, uncontrolled document copies, and security key card access systems are inspected, does that mean that they are considered to be GMP records?<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u95ee\u9898\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5982\u679c\u8fd9\u4e9b\u975eGMP\u8bb0\u5f55\uff0c\u5982\u5168\u5f55\u50cf\u955c\u5934\u3001GMP\u6587\u6863\u4f8b\u5982\u8c03\u67e5\u7684\u8349\u6848\u3001\u975e\u53d7\u63a7\u7684\u6587\u4ef6\u62f7\u8d1d\u4ef6\u4ee5\u53ca\u5b89\u5168\u5bc6\u5319\u5361\u8bbf\u95ee\u7cfb\u7edf\u53d7\u5230\u68c0\u67e5\uff0c\u662f\u5426\u610f\u5473\u7740\u5b83\u4eec\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\uff1f<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Clarification:&nbsp;<\/strong>No. When generated to satisfy a CGMP requirement, all data become a CGMP record. But the fact that a non-GMP record may be subject to inspection or may be the source of an inspectional observation pertaining to a GMP issue does not turn it into a GMP record. However, if a system is intended to provide documented evidence of a GMP function or GMP result then it is a GMP system. For example, if a key card entry system is used beyond employee exit and entry and is used as a log to monitor time spent in an aseptic core for purposes of media fill compliance, then it is being used for GMP purposes and should be clearly defined as such by local procedure. However, if such a system is evaluated on an occasional retrospective basis as part of a GMP investigation to ensure that an employee did not over-stay in the aseptic core, then that does not mean it should be considered a GMP system. Of course, any documentation from that system that is part of an investigation should be kept (in paper or electronic form) as a part of the investigation.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u89e3\u91ca\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4e0d\u3002\u53ea\u6709\u5f53\u6240\u6709\u6570\u636e\u7684\u4ea7\u751f\u5b8c\u5168\u7b26\u5408cGMP\u8981\u6c42\u65f6\uff0c\u5b83\u4eec\u624d\u4f1a\u88ab\u8ba4\u4e3a\u662fcGMP\u8bb0\u5f55\u3002\u4f46\u4e8b\u5b9e\u4e0a\u975eGMP\u8bb0\u5f55\u4e5f\u53ef\u80fd\u4f1a\u53d7\u5230\u76d1\u7ba1\u673a\u6784\u7684\u68c0\u67e5\u6216\u6210\u4e3a\u68c0\u67e5\u65f6\u63d0\u51fa\u7684GMP\u76f8\u5173\u7684\u7f3a\u9677\uff0c\u4f46\u8fd9\u5e76\u4e0d\u4f1a\u4f7f\u5b83\u4eec\u6210\u4e3aGMP\u8bb0\u5f55\u3002\u7136\u800c\u5982\u679c\u4e00\u4e2a\u7cfb\u7edf\u7528\u4e8e\u4e3aGMP\u6d3b\u52a8\u6216GMP\u7ed3\u679c\u63d0\u4f9b\u4e66\u9762\u7684\u8bc1\u636e\uff0c\u90a3\u4e48\u5b83\u5c31\u662fGMP\u7cfb\u7edf\u3002\u4f8b\u5982\u5bc6\u5319\u5361\u8bbf\u95ee\u7cfb\u7edf\u7528\u4e8e\u8bb0\u5f55\u5458\u5de5\u7684\u9000\u51fa\u548c\u8fdb\u5165\u5e76\u4e14\u4f5c\u4e3a\u65e0\u83cc\u6838\u5fc3\u533a\u57df\u8fdb\u884c\u7684\u57f9\u517b\u57fa\u704c\u88c5\u6240\u82b1\u65f6\u95f4\u662f\u5426\u5408\u89c4\u7684\u76d1\u63a7\u8bb0\u5f55\uff0c\u90a3\u4e48\u5b83\u5c31\u662f\u4f5c\u4e3aGMP\u7528\u9014\u5728\u4f7f\u7528\u5e76\u4e14\u5fc5\u987b\u5728\u516c\u53f8\u5236\u5ea6\u4e2d\u660e\u786e\u89c4\u5b9a\u3002\u7136\u800c\uff0c\u5982\u679c\u8fd9\u4e2a\u7cfb\u7edf\u53ea\u662f\u5076\u5c14\u5728\u67d0\u4e2aGMP\u8c03\u67e5\u4e2d\u8fdb\u884c\u5ba1\u6838\u8bc4\u4f30\u4ee5\u786e\u4fdd\u5458\u5de5\u6ca1\u6709\u5728\u65e0\u83cc\u6838\u5fc3\u533a\u57df\u9017\u7559\u592a\u4e45\uff0c\u90a3\u4e48\u8fd9\u4e2a\u7cfb\u7edf\u5c31\u4e0d\u5e94\u8be5\u662fGMP\u7cfb\u7edf\u3002\u5f53\u7136\u4ece\u8fd9\u4e2a\u7cfb\u7edf\u5f97\u5230\u7684\u4efb\u4f55\u6587\u6863\u90fd\u53ef\u4ee5\u4f5c\u4e3a\u8c03\u67e5\u7684\u4e00\u90e8\u5206\u5e76\u5e94\u7559\u5b58\uff08\u53ef\u4ee5\u662f\u7eb8\u8d28\u6216\u7535\u5b50\u683c\u5f0f\uff09\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Question 7: Use of shredders&nbsp;<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7591\u95ee7\uff1a\u788e\u7eb8\u673a\u7684\u4f7f\u7528<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Context:<\/strong>&nbsp;There is no GMP requirement prohibiting the placement or use of shredders in a facility. However, in light of recent observations relating to shredders and shredding, more guidance on shredders and document management would be helpful.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u80cc\u666f\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6ca1\u6709\u4efb\u4f55GMP\u8981\u6c42\u7981\u6b62\u5728\u5de5\u5382\u6446\u653e\u6216\u4f7f\u7528\u788e\u7eb8\u673a\u3002\u4f46\u662f\u6839\u636e\u6700\u8fd1\u548c\u788e\u7eb8\u673a\u4ee5\u53ca\u7c89\u788e\u76f8\u5173\u7684\u7f3a\u9677\u9879\uff0c\u66f4\u591a\u7684\u788e\u7eb8\u673a\u548c\u6587\u6863\u7ba1\u7406\u7684\u6307\u5357\u4f1a\u5e26\u6765\u66f4\u591a\u7684\u5e2e\u52a9\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Issue:&nbsp;<\/strong>What restrictions pertain to the placement and use of shredders?<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u95ee\u9898\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u788e\u7eb8\u673a\u6446\u653e\u548c\u4f7f\u7528\u76f8\u5173\u7684\u9650\u5236\u6709\u54ea\u4e9b\uff1f<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Clarification:&nbsp;<\/strong>There are no restrictions on the placement of shredders in a facility. However, due to the risk of unauthorized shredding of GMP records, it is recommended that firms prohibit shredders or other means of potential unauthorized document destruction in areas where GMP functions are performed. This especially includes those areas that create raw data, including production, warehouse, and laboratory areas, where the risk is more acute. It is acceptable to have shredders in areas that do not generate GMP records and\/or documents, although procedural controls are advisable. These departments can include HR, finance, and other management areas. With respect to use of shredders, non-GMP records can be destroyed through whatever means a firm decides, including shredding (as long as such destruction does not violate corporate document retention policies). GMP records can be destroyed only when they have passed their retention period or if a true copy is being retained in place of original records. For purposes of preserving confidentiality, firms may choose to provide secure bins for documents that require destruction in areas where there are not shredders. If those bins are in or near a GMP area, it is recommended that firms create procedures defining how destruction is accomplished. For example, Quality Unit review of bin contents may be appropriate in certain circumstances, such as during an audit or in cases of suspicion of inappropriate document or data management. In a Research and Development department, there may be GMP and non-GMP studies. It is advisable to create procedures and controls to prevent unauthorized destruction of GMP records in R&amp;D. Similarly, there are no restrictions on placement of correction fluid (e.g., Wite-Out) and sticky notes such as Post-It Notes, but it is advisable to prohibit them in GMP areas.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u89e3\u91ca\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5728\u5de5\u5382\u4e2d\u5e76\u4e0d\u9650\u5236\u6446\u653e\u548c\u4f7f\u7528\u788e\u7eb8\u673a\u3002\u4f46\u662f\uff0c\u56e0\u4e3a\u5b58\u5728GMP\u8bb0\u5f55\u4f1a\u88ab\u7c89\u788e\u7684\u98ce\u9669\uff0c\u5efa\u8bae\u516c\u53f8\u7981\u6b62\u5728GMP\u76f8\u5173\u6d3b\u52a8\u8fdb\u884c\u7684\u5730\u65b9\u6446\u653e\u788e\u7eb8\u673a\u6216\u5176\u4ed6\u672a\u7ecf\u6388\u6743\u7684\u6587\u4ef6\u9500\u6bc1\u8bbe\u65bd\uff0c\u7279\u522b\u662f\u539f\u59cb\u8bb0\u5f55\u751f\u6210\u7684\u533a\u57df\uff0c\u5305\u62ec\u751f\u4ea7\u90e8\u3001\u4ed3\u5e93\u548c\u5b9e\u9a8c\u5ba4\u533a\u57df\uff0c\u8fd9\u4e9b\u533a\u57df\u4e2d\u5b58\u5728\u7684\u98ce\u9669\u66f4\u4e3a\u4e25\u91cd\u3002\u53ef\u4ee5\u5728\u4e00\u4e9b\u4e0d\u4ea7\u751fGMP\u8bb0\u5f55\u548c\/\u6216\u6587\u6863\u7684\u533a\u57df\u653e\u7f6e\u788e\u7eb8\u673a\uff0c\u5f53\u7136\u6700\u597d\u6709\u63a7\u5236\u7a0b\u5e8f\u3002\u8fd9\u4e9b\u90e8\u95e8\u5305\u62ec\u4eba\u529b\u8d44\u6e90\u90e8\u3001\u8d22\u52a1\u90e8\u548c\/\u6216\u5176\u4ed6\u7ba1\u7406\u533a\u57df\u3002\u5bf9\u4e8e\u788e\u7eb8\u673a\u7684\u4f7f\u7528\uff0c\u53ef\u4ee5\u901a\u8fc7\u516c\u53f8\u51b3\u5b9a\u7684\u4efb\u4f55\u65b9\u5f0f\u9500\u6bc1\u975eGMP\u8bb0\u5f55\uff0c\u5305\u62ec\u7c89\u788e\uff08\u53ea\u8981\u4e0d\u8fdd\u53cd\u516c\u53f8\u7684\u6587\u6863\u7559\u5b58\u653f\u7b56\uff09\u3002\u53ea\u6709\u5f53GMP\u6587\u6863\u8fc7\u513f\u4fdd\u5b58\u6709\u6548\u671f\u65f6\uff0c\u5b83\u4eec\u624d\u53ef\u4ee5\u88ab\u9500\u6bc1\uff0c\u6216\u8005\u7528\u771f\u5b9e\u526f\u672c\u53d6\u4ee3\u539f\u59cb\u8bb0\u5f55\u3002\u4e3a\u4fdd\u62a4\u673a\u5bc6\uff0c\u5728\u6ca1\u6709\u788e\u7eb8\u673a\u7684\u533a\u57df\u516c\u53f8\u53ef\u4ee5\u9009\u62e9\u63d0\u4f9b\u5b89\u5168\u6587\u4ef6\u7bb1\u6765\u4fdd\u5b58\u8be5\u533a\u57df\u9700\u8981\u9500\u6bc1\u7684\u8bb0\u5f55\u3002\u5982\u679c\u5b89\u5168\u7bb1\u653e\u5728GMP\u533a\u57df\u6216\u9644\u8fd1\uff0c\u5efa\u8bae\u516c\u53f8\u5efa\u7acb\u76f8\u5e94\u7684\u5236\u5ea6\u660e\u786e\u5982\u4f55\u5b8c\u6210\u9500\u6bc1\u3002\u4f8b\u5982\uff0c\u67d0\u4e9b\u60c5\u51b5\u5982\u5ba1\u8ba1\u671f\u95f4\u6216\u6000\u7591\u6587\u6863\u6216\u6570\u636e\u7ba1\u7406\u4e0d\u5f53\u7684\u60c5\u51b5\u4e0b\uff0c\u8d28\u91cf\u90e8\u95e8\u5ba1\u6838\u5b89\u5168\u6587\u4ef6\u7bb1\u5185\u7684\u6587\u4ef6\u53ef\u80fd\u6bd4\u8f83\u5408\u9002\u3002\u5728\u7814\u53d1\u90e8\u95e8\uff0c\u53ef\u80fd\u5b58\u5728GMP\u548c\u975eGMP\u7814\u7a76\u3002\u660e\u667a\u7684\u505a\u6cd5\u662f\u5236\u5b9a\u76f8\u5e94\u7684\u5236\u5ea6\u548c\u63a7\u5236\u63aa\u65bd\u9632\u6b62\u7814\u53d1\u90e8\u95e8\u5185\u672a\u7ecf\u6388\u6743\u7684GMP\u8bb0\u5f55\u9500\u6bc1\u884c\u4e3a\u3002\u7c7b\u4f3c\u5730\uff0c\u5bf9\u4e8e\u4fee\u6b63\u6db2\uff08\u4f8b\u5982\u4fee\u6b63\u7b14\uff09\u548c\u4fbf\u7b7e\u6761\uff08\u4f8b\u5982\u4fbf\u5229\u8d34\uff09\u7684\u9632\u6b62\u4e5f\u6ca1\u6709\u4efb\u4f55\u9650\u5236\uff0c\u4f46\u662f\u4e5f\u5efa\u8bae\u5728GMP\u533a\u57df\u7981\u6b62\u653e\u7f6e\u548c\u4f7f\u7528\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Question 8: Retention of closed circuit television(CCTV)&nbsp;<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7591\u95ee8\uff1a\u76d1\u63a7\u5f55\u50cf\uff08CCTV\uff09\u7684\u4fdd\u5b58<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Context:&nbsp;<\/strong>Firms are unclear what is required for retention of closed circuit television (CCTV) footage.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u80cc\u666f\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u516c\u53f8\u4e0d\u6e05\u695a\u5bf9\u4e8e\u95ed\u8def\u7535\u89c6\uff08CCTV\uff09\u7684\u7559\u5b58\u6709\u4f55\u8981\u6c42\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Issue:&nbsp;<\/strong>For how long does a firm need to retain CCTV footage?<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u95ee\u9898\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u516c\u53f8\u9700\u8981\u4fdd\u5b58CCTV\u5f71\u50cf\u591a\u4e45\uff1f<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Clarification:<\/strong>&nbsp;CCTV footage from cameras that do not serve a GMP purpose, such as security cameras, should be handled in accordance with applicable firm procedures and retention policies. In general, there is not a GMP requirement to use CCTV. If CCTV footage is serving a GMP purpose, such as for batch release, then the footage should be retained as GMP documentation because it is part of the raw data supporting the disposition of the batch. It is not a GMP requirement to record aseptic process simulation\/media fills, nor is retention of such videos required, unless the video is used as the primary documentation of a GMP operation (activity) that is not documented by other means (such as significant activities that are not documented on the batch record or control records for the process simulation batch). Please note, however, that it is a cGMP expectation to make a video of a smoke study validation. This video is the raw data supporting the qualification of a controlled environment, and the video should be retained as a GMP record. Aspects of local data privacy requirements also need to be considered in defining local procedures.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u89e3\u91ca\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4e00\u4e9b\u4ece\u6444\u50cf\u673a\u4e2d\u5f97\u5230\u7684CCTV\u5f71\u50cf\u5e76\u4e0d\u662f\u7528\u4e8eGMP\u7528\u9014\uff0c\u4f8b\u5982\u5b89\u5168\u5f55\u50cf\u3002\u8fd9\u4e9b\u5f71\u50cf\u5e94\u6309\u7167\u516c\u53f8\u76f8\u5e94\u7684\u5236\u5ea6\u548c\u7559\u5b58\u653f\u7b56\u8fdb\u884c\u5904\u7406\u3002\u4e00\u822c\u6765\u8bf4\uff0c\u5bf9\u4e8eCCTV\u7684\u4f7f\u7528\u5e76\u6ca1\u6709GMP\u8981\u6c42\u3002\u5982\u679cCCTV\u5f71\u50cf\u7528\u4e8eGMP\u7528\u9014\uff0c\u4f8b\u5982\u6279\u7684\u653e\u884c\uff0c\u90a3\u4e48\u8fd9\u4e9b\u5f71\u50cf\u5e94\u6309\u7167GMP\u6587\u6863\u8fdb\u884c\u7559\u5b58\uff0c\u56e0\u4e3a\u5b83\u4eec\u662f\u652f\u6301\u6279\u5904\u7f6e\u539f\u59cb\u6570\u636e\u7684\u4e00\u90e8\u5206\u3002\u5bf9\u65e0\u83cc\u5de5\u827a\u6a21\u62df\/\u57f9\u517b\u57fa\u704c\u88c5\u8fdb\u884c\u5f55\u50cf\u4ee5\u53ca\u5bf9\u8fd9\u4e9b\u5f55\u50cf\u7684\u4fdd\u5b58\u5e76\u4e0d\u662fGMP\u8981\u6c42\uff0c\u9664\u975e\u5f55\u50cf\u88ab\u7528\u4f5cGMP\u64cd\u4f5c\uff08\u6d3b\u52a8\uff09\u7684\u4e3b\u8981\u6587\u4ef6\u8d44\u6599\uff0c\u800c\u6ca1\u6709\u5176\u4ed6\u65b9\u5f0f\u7684\u8bb0\u5f55\uff08\u4f8b\u5982\u5728\u5de5\u827a\u6a21\u62df\u6279\u751f\u4ea7\u65f6\uff0c\u91cd\u8981\u7684\u6d3b\u52a8\u5e76\u6ca1\u6709\u8bb0\u5f55\u5728\u6279\u8bb0\u5f55\u6216\u63a7\u5236\u8bb0\u5f55\u4e2d\uff09\u3002\u7136\u800c\u9700\u8981\u6ce8\u610f\u7684\u662f\uff0ccGMP\u671f\u671b\u5bf9\u70df\u96fe\u7814\u7a76\u9a8c\u8bc1\u8fdb\u884c\u5f55\u50cf\u3002\u8fd9\u4efd\u5f55\u50cf\u662f\u652f\u6301\u53d7\u63a7\u73af\u5883\u786e\u8ba4\u7684\u539f\u59cb\u6570\u636e\u5e76\u4e14\u8be5\u5f55\u50cf\u5e94\u6309\u7167GMP\u8bb0\u5f55\u6765\u4fdd\u5b58\u3002\u53e6\u5916\u5728\u5236\u5b9a\u516c\u53f8\u5236\u5ea6\u65f6\u4e5f\u9700\u8981\u8003\u8651\u672c\u5730\u6570\u636e\u9690\u79c1\u9700\u6c42\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Question 9: Data capture capabilities<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7591\u95ee9\uff1a\u6570\u636e\u91c7\u96c6\u529f\u80fd<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Context:&nbsp;<\/strong>Many pieces of production and laboratory equipment have extensive data capture capabilities. Firms are unclear whether they can disable unnecessary functions and\/or rely on alternate recordkeeping systems.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u80cc\u666f\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u9700\u8981\u751f\u4ea7\u548c\u5b9e\u9a8c\u5ba4\u8bbe\u5907\u5747\u5177\u5907\u5e7f\u6cdb\u7684\u6570\u636e\u91c7\u96c6\u529f\u80fd\u3002\u516c\u53f8\u4e0d\u6e05\u695a\u4ed6\u4eec\u662f\u5426\u53ef\u4ee5\u5173\u95ed\u8fd9\u4e9b\u4e0d\u9700\u8981\u7684\u529f\u80fd\u548c\/\u6216\u4f9d\u8d56\u5907\u7528\u7684\u8bb0\u5f55\u4fdd\u5b58\u7cfb\u7edf\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Issue:<\/strong>&nbsp;If a piece of production or laboratory equipment has electronic data storage capability, is a firm required to utilize that capability?<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u95ee\u9898\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5982\u679c\u67d0\u53f0\u751f\u4ea7\u6216\u5b9e\u9a8c\u5ba4\u8bbe\u5907\u5177\u6709\u7535\u5b50\u6570\u636e\u5b58\u50a8\u529f\u80fd\uff0c\u516c\u53f8\u662f\u5426\u5fc5\u987b\u4f7f\u7528\u8fd9\u79cd\u529f\u80fd\uff1f<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Clarification:&nbsp;<\/strong>If production or laboratory equipment captures data that is required under GMPs, it must be used unless there is a reliable and complete alternate paper or electronic documentation system in place that meets GMP requirements. Please note, however, that if electronic raw data is dynamic, then a fixed\/static paper or electronic record may not constitute a complete copy of the original record because that record may be missing GMP-required data that is captured in the electronic system. Also, if there is an electronic audit trail, it should not be turned off in favor of a manual audit trail as a manual audit trail is necessarily less robust than an automatic one. If an automated data capture system is disabled, it is advisable to document a good faith rationale for disabling the system. Firms should be prepared to defend the rationale during inspection if necessary, including evidence that all data required by cGMP is captured and retained by alternate system(s) as applicable. If an electronic data capture system is not disabled and is not utilized for GMP purposes, firms\u2019 procedures should clearly identify what system is used as the source of raw data and what system is not. It is also recommended that firms review the non-disabled system\u2019s data as a part of their procedures. The reason for this is that any data that is captured may be inspected by FDA and could be the basis for concerns about data integrity, for example in the case of discrepancies between data in the two different systems.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u89e3\u91ca\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5982\u679c\u751f\u4ea7\u6216\u5b9e\u9a8c\u5ba4\u8bbe\u5907\u91c7\u96c6\u7684\u6570\u636e\u88ab\u7528\u4e8eGMP\uff0c\u90a3\u4e48\u8fd9\u9879\u529f\u80fd\u5fc5\u987b\u88ab\u4f7f\u7528\uff0c\u9664\u975e\u53e6\u5916\u6709\u7b26\u5408GMP\u8981\u6c42\u4e14\u53ef\u9760\u548c\u5b8c\u6574\u7684\u66ff\u4ee3\u7eb8\u8d28\u6216\u7535\u5b50\u6587\u6863\u7cfb\u7edf\u3002\u8bf7\u6ce8\u610f\u5982\u679c\u7535\u5b50\u539f\u59cb\u6570\u636e\u662f\u52a8\u6001\u7684\uff0c\u90a3\u4e48\u56fa\u5b9a\/\u9759\u6001\u7684\u7eb8\u8d28\u6216\u7535\u5b50\u8bb0\u5f55\u53ef\u80fd\u5e76\u4e0d\u5c5e\u4e8e\u539f\u59cb\u8bb0\u5f55\u7684\u5b8c\u6574\u62f7\u8d1d\uff0c\u56e0\u4e3a\u8fd9\u79cd\u8bb0\u5f55\u53ef\u80fd\u4f1a\u4e22\u5931\u7535\u5b50\u7cfb\u7edf\u91c7\u96c6\u5230\u7684GMP\u6570\u636e\u3002\u540c\u6837\uff0c\u5982\u679c\u7cfb\u7edf\u5177\u6709\u7535\u5b50\u5ba1\u8ba1\u8ffd\u8e2a\u529f\u80fd\uff0c\u5219\u8be5\u529f\u80fd\u4e0d\u5e94\u88ab\u5173\u95ed\u4ee5\u652f\u6301\u624b\u52a8\u5ba1\u8ba1\u8ffd\u8e2a\uff0c\u56e0\u4e3a\u624b\u52a8\u5ba1\u8ba1\u8ffd\u8e2a\u5fc5\u7136\u6ca1\u6709\u81ea\u52a8\u5ba1\u8ba1\u8ffd\u8e2a\u53ef\u9760\u3002\u5982\u679c\u81ea\u52a8\u5316\u6570\u636e\u91c7\u96c6\u7cfb\u7edf\u88ab\u5173\u95ed\uff0c\u6700\u597d\u8bb0\u5f55\u4e0b\u5173\u95ed\u8fd9\u4e2a\u7cfb\u7edf\u7684\u5408\u7406\u7406\u7531\u3002\u516c\u53f8\u5e94\u51c6\u5907\u597d\u5728\u68c0\u67e5\u671f\u95f4\u5982\u6709\u5fc5\u8981\u7684\u8bdd\u8be6\u7ec6\u9610\u660e\u8fd9\u4e2a\u7406\u7531\uff0c\u5305\u62ec\u6240\u6709GMP\u8981\u6c42\u7684\u6570\u636e\u90fd\u5df2\u7ecf\u88ab\u91c7\u96c6\u7684\u8bc1\u636e\u4ee5\u53ca\u5408\u9002\u7684\u8bdd\u6709\u53e6\u5916\u5907\u7528\u7684\u7cfb\u7edf\u7559\u5b58\u3002\u5982\u679c\u67d0\u4e2a\u7535\u5b50\u6570\u636e\u91c7\u96c6\u7cfb\u7edf\u6ca1\u6709\u88ab\u5173\u95ed\u5e76\u4e14\u6ca1\u6709\u7528\u4e8eGMP\u7528\u9014\uff0c\u516c\u53f8\u5e94\u5728\u5176\u5236\u5ea6\u4e2d\u6e05\u6670\u6807\u660e\u54ea\u4e9b\u662f\u4ea7\u751f\u539f\u59cb\u6570\u636e\u7684\u7cfb\u7edf\uff0c\u54ea\u4e9b\u4e0d\u662f\u4ea7\u751f\u539f\u59cb\u6570\u636e\u7684\u7cfb\u7edf\u3002\u5efa\u8bae\u516c\u53f8\u5728\u5176\u5236\u5ea6\u4e2d\u89c4\u5b9a\u5ba1\u6838\u8fd9\u4e9b\u6ca1\u6709\u5173\u95ed\u7cfb\u7edf\u7684\u6570\u636e\u3002\u8fd9\u6837\u505a\u7684\u539f\u56e0\u662f\u8fd9\u4e9b\u7cfb\u7edf\u91c7\u96c6\u5230\u7684\u6570\u636e\u6709\u53ef\u80fd\u53d7\u5230FDA\u7684\u68c0\u67e5\u5e76\u4e14\u53ef\u80fd\u4f1a\u6210\u4e3a\u6570\u636e\u5b8c\u6574\u6027\u7f3a\u9677\u3002\u4f8b\u5982\u4e24\u53f0\u4e0d\u540c\u7684\u7cfb\u7edf\u4e2d\u6570\u636e\u76f8\u4e92\u77db\u76fe\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Question 10: Quality Plans<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7591\u95ee10\uff1a\u8d28\u91cf\u8ba1\u5212<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Context:&nbsp;<\/strong>Firms may be reluctant to create and document quality plans (documentation of their goals and timelines for quality system improvement) for fear of that plan being used as the source of 483 observations.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u80cc\u666f\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u56e0\u4e3a\u62c5\u5fc3\u8d28\u91cf\u8ba1\u5212\u53ef\u80fd\u4f1a\u6210\u4e3a483\u7f3a\u9677\u7684\u6765\u6e90\uff0c\u516c\u53f8\u53ef\u80fd\u4f1a\u4e0d\u613f\u610f\u5efa\u7acb\u548c\u8bb0\u5f55\u8d28\u91cf\u8ba1\u5212\uff08\u8d28\u91cf\u7cfb\u7edf\u6539\u8fdb\u7684\u76ee\u6807\u548c\u65f6\u95f4\u7ebf\uff09\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Issue:&nbsp;<\/strong>If a firm has a quality plan, will an FDA investigator use that plan as the basis for 483 observations?<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u95ee\u9898\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5982\u679c\u516c\u53f8\u6709\u8d28\u91cf\u8ba1\u5212\uff0cFDA\u68c0\u67e5\u5458\u4f1a\u4e0d\u4f1a\u5728\u8d28\u91cf\u8ba1\u5212\u4e0a\u63d0\u51fa483\u7f3a\u9677\uff1f<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\">Clarification: If a firm has a quality plan, an investigator may assess the sufficiency of that plan and whether the plan is being fully and timely executed. The fact that a firm has a reasonable quality plan in place may not prevent observations but can be evidence of a firm\u2019s willingness to selfidentify and address issues. The adequacy of the firm\u2019s plan and the progress that the firm has made in executing the plan may be viewed by a regulator as a positive indicator of the firm\u2019s status. Using a firm\u2019s quality plan as a roadmap for negative observations could create a disincentive to creation of such plans. Regulators often encourage firms to proactively meet with them if the firm finds data integrity deficiencies, rather than waiting for those issues to be part of an inspection.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u89e3\u91ca\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5982\u679c\u516c\u53f8\u6709\u8d28\u91cf\u8ba1\u5212\uff0c\u68c0\u67e5\u5458\u53ef\u80fd\u4f1a\u8bc4\u4f30\u8ba1\u5212\u7684\u5145\u5206\u6027\u4ee5\u53ca\u8ba1\u5212\u662f\u5426\u88ab\u5b8c\u6574\u4e14\u53ca\u65f6\u5730\u6267\u884c\u3002\u4e8b\u5b9e\u4e0a\uff0c\u5982\u679c\u516c\u53f8\u7684\u8d28\u91cf\u8ba1\u5212\u5408\u7406\u7684\u8bdd\uff0c\u5c3d\u7ba1\u4e0d\u4f1a\u907f\u514d483\u7684\u53d1\u51fa\uff0c\u4f46\u662f\u53ef\u4ee5\u4f5c\u4e3a\u516c\u53f8\u81ea\u6211\u8ba4\u540c\u4ee5\u53ca\u89e3\u51b3\u95ee\u9898\u51b3\u5fc3\u7684\u8bc1\u636e\u3002\u516c\u53f8\u8ba1\u5212\u7684\u5145\u5206\u6027\u548c\u6267\u884c\u8ba1\u5212\u53d6\u5f97\u7684\u8fdb\u5c55\u53ef\u80fd\u4f1a\u4f5c\u4e3a\u76d1\u7ba1\u8005\u89c6\u4e3a\u516c\u53f8\u4e3b\u89c2\u79ef\u6781\u7684\u6307\u6807\u3002\u5c06\u8d28\u91cf\u8ba1\u5212\u4f5c\u4e3a\u68c0\u67e5\u51fa\u8d1f\u9762\u95ee\u9898\u7684\u8def\u6807\u4f1a\u963b\u788d\u8ba1\u5212\u7684\u5236\u5b9a\uff0c\u800c\u76d1\u7ba1\u8005\u901a\u5e38\u9f13\u52b1\u516c\u53f8\u5982\u679c\u53d1\u73b0\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u4e3b\u52a8\u79ef\u6781\u5730\u53bb\u89e3\u51b3\uff0c\u800c\u4e0d\u662f\u7b49\u5230\u88ab\u68c0\u67e5\u51fa\u6765\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Question 11: Questioning investigator actions in the field&nbsp;<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u73b0\u573a\u8d28\u8be2\u68c0\u67e5\u5458\u7684\u884c\u4e3a<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Context:&nbsp;<\/strong>There is a diversity of FDA investigators in the field, and inspections can unfold in a variety of ways. Some firms are unsure of what to do if they perceive that an investigator is acting inappropriately or inspecting non-GMP records, documents, or facilities without cause.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u80cc\u666f\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u73b0\u573a\u68c0\u67e5\u7684FDA\u68c0\u67e5\u5458\u4e0d\u5c3d\u76f8\u540c\uff0c\u800c\u4e14\u68c0\u67e5\u53ef\u4ee5\u4ee5\u591a\u79cd\u65b9\u5f0f\u5f00\u5c55\u3002\u4e00\u4e9b\u516c\u53f8\u4e0d\u786e\u5b9a\u5982\u679c\u4ed6\u4eec\u89c9\u5f97\u68c0\u67e5\u5458\u884c\u4e3a\u4e0d\u5f53\u6216\u8005\u6ca1\u6709\u4efb\u4f55\u539f\u56e0\u68c0\u67e5\u4e86\u975eGMP\u4e0b\u7684\u8bb0\u5f55\u3001\u6587\u4ef6\u6216\u5382\u623f\u8bbe\u65bd\uff0c\u4ed6\u4eec\u5e94\u8be5\u600e\u4e48\u505a\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Issue:&nbsp;<\/strong>If a firm believes that an FDA investigator is acting inappropriately or inspecting non-GMP records, documents or facilities without an apparent cause, what should the firm do?<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u95ee\u9898\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5982\u679c\u516c\u53f8\u575a\u4fe1FDA\u68c0\u67e5\u5458\u884c\u4e3a\u4e0d\u5f53\u6216\u8005\u68c0\u67e5\u4e86\u975eGMP\u4e0b\u7684\u8bb0\u5f55\u3001\u6587\u4ef6\u6216\u5382\u623f\u8bbe\u65bd\u800c\u6ca1\u6709\u4efb\u4f55\u786e\u5207\u7684\u7406\u7531\uff0c\u516c\u53f8\u5e94\u8be5\u600e\u4e48\u505a\uff1f<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Clarification:&nbsp;<\/strong>The law defines FDA\u2019s inspectional scope for a drug factory, warehouse, establishment, or lab as including \u201call things therein (including records, files, papers, processes, controls, and facilities) bearing on whether\u201d drugs are adulterated or misbranded or otherwise prohibited by the FD&amp;C Act. The only explicit limits on FDA\u2019s inspectional authority are that it does not extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to inspection), and research data that is beyond the scope of FDA requirements. (See FD&amp;C Act 704.)<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u89e3\u91ca\uff1a<\/span><\/strong><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6cd5\u5f8b\u89c4\u5b9a\u4e86FDA\u5bf9\u5236\u836f\u5382\u3001\u4ed3\u5e93\u3001\u516c\u53f8\u6216\u5b9e\u9a8c\u5ba4\u7684\u68c0\u67e5\u8303\u56f4\u5305\u62ec\u4e86\u201c\u5176\u4e2d\u6240\u6709\u7684\u4e8b\u60c5\uff08\u5305\u62ec\u8bb0\u5f55\u3001\u6587\u4ef6\u3001\u7eb8\u5f20\u3001\u5de5\u827a\u3001\u63a7\u5236\u4ee5\u53ca\u5382\u623f\u8bbe\u65bd\uff09\u53ea\u8981\u201d\u548c\u63ba\u5047\u6216\u662f\u5192\u724c\u836f\u6216\u5176\u4ed6\u8fdd\u53cd\u4e86\u98df\u54c1\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u6848\u7684\u884c\u4e3a\u6709\u5173\u3002\u552f\u4e00\u660e\u786e\u7684\u662fFDA\u68c0\u67e5\u6388\u6743\u6ca1\u6709\u6269\u5c55\u5230\u8d22\u52a1\u6570\u636e\u3001\u9500\u552e\u6570\u636e\u4ee5\u5916\u7684\u88c5\u8fd0\u6570\u636e\u3001\u5b9a\u4ef7\u6570\u636e\u3001\u4eba\u4e8b\u6570\u636e\uff08\u9664\u4e86\u6280\u672f\u548c\u4e13\u4e1a\u4eba\u5458\u5f00\u5c55\u53d7\u68c0\u67e5\u4e1a\u52a1\u8d44\u8d28\u6709\u5173\u7684\u6570\u636e\uff09\u4ee5\u53ca\u8d85\u51fa\u4e86FDA\u8981\u6c42\u7684\u8303\u56f4\u7684\u7814\u7a76\u6570\u636e\uff08\u89c1FD&amp;C Act 704\uff09\u3002<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\">Firms should be aware, however, that FDA interprets its inspectional authority broadly. As FDA has stated, the law \u201cauthorizes FDA to conduct inspections at reasonable times, within reasonable limits, and in a reasonable manner. Although the [law] does not specifically define \u2018reasonable,\u2019 FDA has long maintained that the inspectional authority. . . \u2018extends to what is reasonably necessary to achieve the objective of the inspection.\u2019\u201d (See Guidance for Industry, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (Oct. 2014). In 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law 112-144, was enacted. This law includes a provision that deems a drug to be \u201cadulterated\u201d if the drug \u201chas been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.\u201d Under this law, drug manufacturers that delay, deny, limit, or refuse to permit entry or inspection are potentially subject to regulatory sanctions by FDA including Import Alert, Warning Letter, and Seizure.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7136\u800c\uff0c\u516c\u53f8\u5e94\u610f\u8bc6\u5230FDA\u7684\u68c0\u67e5\u6388\u6743\u8303\u56f4\u76f8\u5f53\u7684\u5e7f\u9614\u3002\u6b63\u5982FDA\u6240\u79f0\uff0c\u6cd5\u5f8b\u201c\u6388\u6743\u7ed9FDA\u53ef\u4ee5\u5728\u4efb\u4f55\u5408\u7406\u7684\u65f6\u95f4\uff0c\u4efb\u4f55\u5408\u7406\u7684\u6743\u9650\u5185\u4ee5\u53ca\u4ee5\u4efb\u4f55\u5408\u7406\u7684\u65b9\u5f0f\u5f00\u5c55\u68c0\u67e5\u3002\u5c3d\u7ba1\u3010\u6cd5\u5f8b\u3011\u6ca1\u6709\u8be6\u7ec6\u5b9a\u4e49\u2018\u5408\u7406\u2019\u4e00\u8bcd\uff0c\u4f46\u662fFDA\u957f\u671f\u4ee5\u6765\u4e00\u76f4\u4fdd\u6301\u68c0\u67e5\u6388\u6743\u6269\u5c55\u81f3\u4e3a\u5b9e\u73b0\u68c0\u67e5\u76ee\u6807\u4efb\u4f55\u5fc5\u7136\u5408\u7406\u7684\u8303\u56f4\u201d\uff08\u89c1\u884c\u4e1a\u6307\u5357-\u6784\u6210\u62d6\u5ef6\u3001\u62d2\u7edd\u3001\u9650\u5236\u6216\u62d2\u7edd\u836f\u7269\u68c0\u67e5\u7684\u60c5\u5f62\uff0c2014\u5e7410\u6708\uff09\u3002\u57282012\u5e74\uff0c\u516c\u4f17\u6cd5\u5f8b112-144\uff0c\u98df\u54c1\u548c\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5b89\u5168\u548c\u521b\u65b0\u65b9\u6cd5\uff08FDASIA\uff09\u9881\u5e03\u3002\u672c\u6cd5\u52a0\u5165\u4e86\u4e00\u4e2a\u6761\u6b3e,\u89c4\u5b9a\u5982\u679c\u836f\u7269\u201d\u5728\u4efb\u4f55\u5ef6\u8bef\u3001\u62d2\u7edd\u6216\u9650\u5236\u68c0\u67e5\u6216\u62d2\u7edd\u8fdb\u5165\u6216\u68c0\u67e5\u7684\u5de5\u5382\u3001\u4ed3\u5e93\u6216\u516c\u53f8\u548c\u6240\u6709\u8005,\u8fd0\u8425\u5546\u6216\u516c\u53f8\u5236\u9020\u3001\u52a0\u5de5\u3001\u5305\u88c5\u3001\u6216\u4fdd\u5b58\u90fd\u88ab\u8ba4\u4e3a\u662f\u63ba\u5047\u836f\u3002\u6839\u636e\u8fd9\u9879\u6cd5\u5f8b\uff0c\u5ef6\u8fdf\u3001\u62d2\u7edd\u3001\u9650\u5236\u6216\u62d2\u7edd\u8fdb\u5165\u6216\u68c0\u67e5\u7684\u836f\u54c1\u751f\u4ea7\u5546\u53ef\u80fd\u4f1a\u53d7\u5230FDA\u7684\u76d1\u7ba1\u5904\u7f5a\uff0c\u5305\u62ec\u8fdb\u53e3\u8b66\u544a\u3001\u8b66\u544a\u4fe1\u548c\u6263\u62bc\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\">One issue that arises is what FDA can inspect, such as whether FDA can inspect the firm\u2019s e-mail system, phone messages, and individuals\u2019 offices. It has also been reported that FDA investigators have requested information or data in a format other than that which is generally used or maintained by the firm, and informed the firm that it would be a refusal of inspection if the firm does not produce the requested information or data in that format.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u90a3\u4e48\u8981\u9762\u5bf9\u7684\u4e00\u4e2a\u95ee\u9898\u662fFDA\u53ef\u4ee5\u68c0\u67e5\u4ec0\u4e48\uff0c\u6bd4\u5982FDA\u662f\u5426\u53ef\u4ee5\u68c0\u67e5\u516c\u53f8\u7684\u7535\u5b50\u90ae\u4ef6\u7cfb\u7edf\u3001\u7535\u8bdd\u77ed\u4fe1\u548c\u4e2a\u4eba\u529e\u516c\u5ba4\u3002\u636e\u62a5\u9053,FDA\u68c0\u67e5\u5458\u8981\u6c42\u63d0\u4f9b\u516c\u53f8\u901a\u5e38\u4f7f\u7528\u6216\u4fdd\u5b58\u683c\u5f0f\u4ee5\u5916\u7684\u4fe1\u606f\u6216\u6570\u636e,\u5e76\u901a\u77e5\u8be5\u516c\u53f8\u5982\u679c\u516c\u53f8\u4e0d\u63d0\u4f9b\u6240\u8bf7\u6c42\u683c\u5f0f,\u7684\u4fe1\u606f\u6216\u6570\u636e\uff0c\u8fd9\u5c06\u88ab\u89c6\u4e3a\u62d2\u7edd\u68c0\u67e5\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"font-size: 14px;\">If a firm believes that an investigator is acting inappropriately or inspecting non-GMP records, documents, or facilities without an apparent cause, the first step is to raise that issue with the investigator. If the firm does not feel it can do so, or that effort is unsuccessful, the firm can contact the District Office at which the investigator works, the ORA ombudsman, or others in ORA or Center management to discuss the issue.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5982\u679c\u516c\u53f8\u575a\u4fe1\u68c0\u67e5\u5458\u884c\u4e3a\u4e0d\u5f53\u6216\u68c0\u67e5\u4e86\u975eGMP\u5f97\u8bb0\u5f55\u3001\u6587\u6863\u6216\u5382\u623f\u8bbe\u65bd\u800c\u6ca1\u6709\u5408\u7406\u7684\u7406\u7531\uff0c\u7b2c\u4e00\u6b65\u8981\u505a\u7684\u662f\u5411\u68c0\u67e5\u5458\u63d0\u51fa\u8fd9\u4e2a\u95ee\u9898\u3002\u5982\u679c\u516c\u53f8\u611f\u89c9\u6ca1\u529e\u6cd5\u8fd9\u6837\u505a\uff0c\u6216\u8005\u5c1d\u8bd5\u5931\u8d25\uff0c\u516c\u53f8\u53ef\u4ee5\u8054\u7cfb\u68c0\u67e5\u5458\u6240\u5728\u7684\u5730\u533a\u529e\u516c\u5ba4\uff0cORA\u76d1\u5bdf\u5458\u6216\u5176\u4ed6ORA\u6216\u4e2d\u5fc3\u7ba1\u7406\u5c42\u8ba8\u8bba\u8fd9\u4e2a\u95ee\u9898\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section>\n<section class=\"cps_inner cps_inner_list js_list_container js_product_container cps_inner_book\">\n<div class=\"cps_inner_wrp js_product_loop_content\"        >\n<div class=\"cps_inner_content\">\n<figure class=\"cps_inner_image_container\">                                                        <\/figure>\n<div class=\"cps_inner_info\">\n<div class=\"cps_inner_info_hd\">\n<h2 class=\"cps_inner_info_title\">2018\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7528\u4e662018\u897f\u836f \u56fd\u5bb6\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u540c\u6b65\u9898\u5e93 \u836f\u5b66\u4e13\u4e1a\u77e5\u8bc6\uff08\u4e00\uff09\uff08\u7b2c\u4e8c\u7248\uff09<\/h2>\n<p class=\"cps_inner_info_desc\">\u4f5c\u8005\uff1a\u56fd\u5bb6\u6267\u4e1a\u836f\u5e08\u8d44\u683c\u8003\u8bd5\u7814\u7a76\u7ec4<\/p>\n<\/p><\/div>\n<div class=\"cps_inner_info_ft\">\n<div class=\"cps_inner_info_ft_left\">                                      <span class=\"cps_inner_info_from\">                                          <span   style=\"background: url(http:\/\/mmbiz.qpic.cn\/mmbiz_png\/6nVmK0mHaRr8fd8C4yNUm5BrcwmJ17I867w7sZwrxtAmG0NdTKhZj8eAEeRt0Ycgc9pnL4ib77PJ0UKDoT43MsA\/0) no-repeat center;                                          background-size: contain;\" class=\"cps_inner_ic_from\"><\/span>\u5f53\u5f53                                      <\/span>  \t\t\t\t\t\t\t\t\t                                    <span class=\"cps_inner_info_adTag js_cps_adTag\">\u5e7f\u544a<\/span>  \t\t\t\t\t\t\t\t\t                                <\/div>\n<p>                                  <span class=\"cps_inner_btn_cps_info\"><i class=\"cps_inner_ic_miniapp\"><\/i><span class='js_btn_word'>\u8d2d\u4e70<\/span><\/span>                              <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n<h2 class=\"rich_media_title\" style=\"\" sans=\"sans\" gb=\"gb\" yahei=\"yahei\" none=\"none\" px=\"px\" normal=\"normal\" neue=\"neue\" sc=\"sc\" ui=\"ui\" helvetica=\"helvetica\" center=\"center\" rgb=\"rgb\"><span style=\"color: rgb(255, 0, 0);font-size: 14px;\">PDA TR60\u4e2d\u5173\u4e8e\u5173\u952e\u8d28\u91cf\u5c5e\u6027CQAs\u7684\u63cf\u8ff0<\/span><\/h2>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">A Critical Quality Attribute (CQA) is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. CQAs can be associated with drug substances, drug products, excipients, intermediates (in-process materials), and container\/closure components. At an early stage of process development, the information available on product attributes may be limited. For this reason, the first set of CQAs may come from prior knowledge obtained during early development and\/or from similar products rather than from extensive product characterization. The degree of criticality assigned to quality attributes is derived using risk-based tools and the potential impact of the attributes on safety and efficacy. Following comprehensive assessments of scientific evidence and risk, quality attributes are ranked according to the degree of criticality, which may be a continuum that more accurately reflects the complexity of structure-function relationships and varying levels of uncertainty around attribute classification. Attributes not assigned as CQAs should also be considered in the development of the process.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08CQA\uff09\u662f\u4e3a\u4e86\u4fdd\u8bc1\u9884\u671f\u836f\u54c1\u8d28\u91cf\u9700\u8981\u4fdd\u6301<span style=\"margin: 0px;padding: 0px;text-align: justify;font-size: 14px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5728\u9002\u5b9c\u7684\u9650\u5ea6\u3001\u8303\u56f4\u6216\u5206\u5e03\u8303\u56f4\u5185<\/span>\u7684\u7269\u7406\u7684\u3001\u5316\u5b66\u7684\u3001\u751f\u7269\u7684\u6216\u5fae\u751f\u7269\u7684\u6027\u8d28\u6216\u7279\u6027\u3002CQAs \u53ef\u80fd\u4e0e\u539f\u6599\u836f\u3001\u5236\u5242\u4ea7\u54c1\u3001\u8f85\u6599\u3001\u4e2d\u95f4\u4ea7\u54c1\uff08\u4e2d\u95f4\u7269\u6599\uff09\u548c\u5bb9\u5668\/\u5bc6\u5c01\u7cfb\u7edf\u6709\u5173\u3002\u5728\u5de5\u827a\u5f00\u53d1\u7684\u65e9\u671f\u53ef\u4ee5\u9650\u5b9a\u4e3a\u53ef\u7528\u7684\u4ea7\u54c1\u5c5e\u6027\u4fe1\u606f\u3002\u4e3a\u6b64\uff0c\u8d77\u521d\u8bbe\u5b9a\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u53ef\u80fd\u6765\u81ea\u65e9\u671f\u5f00\u53d1\u548c\/\u6216\u7c7b\u4f3c\u4ea7\u54c1\u83b7\u53d6\u7684\u5148\u524d\u7684\u77e5\u8bc6\u800c\u4e0d\u662f\u5927\u91cf\u7684\u4ea7\u54c1\u6027\u8d28\u3002\u8d28\u91cf\u5c5e\u6027\u7684\u5173\u952e\u7a0b\u5ea6\u6765\u6e90\u4e8e\u5229\u7528\u57fa\u4e8e\u98ce\u9669\u7684\u5de5\u5177\u548c\u8d28\u91cf\u5c5e\u6027\u5bf9\u5b89\u5168\u6027\u4e0e\u6709\u6548\u6027\u7684\u6f5c\u5728\u5f71\u54cd\u3002\u5728\u5bf9\u79d1\u5b66\u8bc1\u636e\u548c\u98ce\u9669\u8fdb\u884c\u4e86\u7efc\u5408\u8bc4\u4f30\u4e4b\u540e\uff0c\u6839\u636e\u5173\u952e\u6027\u7a0b\u5ea6\u5bf9\u8d28\u91cf\u5c5e\u6027\u6392\u5e8f\uff0c\u8fd9\u6837\u53ef\u80fd\u66f4\u80fd\u53cd\u6620\u7ed3\u6784-\u529f\u80fd\u5173\u7cfb\u7684\u590d\u6742\u6027\u548c\u5c5e\u6027\u5206\u7c7b\u4e0d\u786e\u5b9a\u6027\u7684\u53d8\u5316\u7a0b\u5ea6\u3002\u4e0eCQAs \u65e0\u5173\u7684\u5c5e\u6027\u5728\u5de5\u827a\u5f00\u53d1\u4e2d\u4e5f\u5e94\u52a0\u4ee5\u8003\u8651\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">CQAs are not synonymous with specifications. In addition, there is not necessarily a one-to-one relationship between CQAs and specifications. Specifications are a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the tests described. Several product attributes identified as CQAs may be detected by a single test method, and therefore, built into a single test specification (e.g., API solubility, hardness, porosity are CQAs evaluated using a single test: dissolution). Some CQAs may not be included in the specifications if they are very well-controlled and consistently achieved within the process (e.g., viral clearance is not tested for every batch), while some attributes not considered critical may be included in the specifications.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">CQAs \u4e0e\u8d28\u91cf\u6807\u51c6\u4e0d\u662f\u540c\u4e49\u8bcd\u3002\u53e6\u5916\uff0c\u4e5f\u6ca1\u6709\u5fc5\u8981\u5c06CQAs \u4e0e\u8d28\u91cf\u6807\u51c6\u4e00\u4e00\u5bf9\u5e94\u3002\u8d28\u91cf\u6807\u51c6\u662f\u68c0\u9a8c\u3001\u53c2\u7167\u7684\u5206\u6790\u7a0b\u5e8f\u548c\u7528\u6570\u503c\u9650\u5ea6\u3001\u8303\u56f4\u63cf\u8ff0\u7684\u9002\u5f53\u7684\u53ef\u63a5\u53d7\u6807\u51c6\u6216\u63cf\u8ff0\u7684\u6d4b\u8bd5\u7684\u5176\u4ed6\u6807\u51c6\u7684\u5217\u8868\u3002\u88ab\u786e\u5b9a\u4e3aCQAs \u7684\u51e0\u4e2a\u4ea7\u54c1\u5c5e\u6027\u53ef\u4ee5\u7528\u5355\u4e00\u65b9\u6cd5\u68c0\u67e5\uff0c\u56e0\u6b64\uff0c\u53ef\u4ee5\u5efa\u7acb\u5355\u4e00\u7684\u6d4b\u8bd5\u6807\u51c6\uff08\u4f8b\u5982\uff1aAPI \u7684\u6eb6\u89e3\u5ea6\u3001\u786c\u5ea6\u3001\u5b54\u9699\u5ea6\u662f\u53ef\u4ee5\u7528\u4e00\u4e2a\u8bd5\u9a8c-\u6eb6\u51fa\u5ea6\u6765\u8bc4\u4ef7\u7684CQAs\uff09\u3002\u6709\u4e9b\u5728\u5de5\u827a\u8fc7\u7a0b\u4e2d\u5bb9\u6613\u63a7\u5236\u548c\u8fbe\u5230\u7684CQAs \u53ef\u4ee5\u4e0d\u5305\u542b\u5728\u8d28\u91cf\u6807\u51c6\u4e2d\uff08\u5982\u75c5\u6bd2\u6e05\u9664\u4e0d\u662f\u6bcf\u6279\u68c0\u67e5\uff09\uff0c\u800c\u4e00\u4e9b\u4e0d\u662f\u5173\u952e\u6027\u7684\u5c5e\u6027\u4e5f\u53ef\u80fd\u5236\u5b9a\u5728\u8d28\u91cf\u6807\u51c6\u4e2d\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">The identification of potential CQAs is an ongoing activity initiated early in product development. It makes use of general knowledge about the product and its application, as well as available clinical and non-clinical data. CQAs are subject to change in the early stages of product development, and thus require a quality risk management approach that evolves as knowledge about the product and process is generated (for discussion, see Section 6.1 \u201cApplication of Risk Management\u201d). CQAs for commercial products should be defined prior to initiation of Stage 2 activities.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><br  \/><\/p>\n<p><span style=\"font-size: 14px;\">\u6f5c\u5728CQAs \u7684\u786e\u5b9a\u662f\u4e00\u4e2a\u59cb\u4e8e\u4ea7\u54c1\u5f00\u53d1\u65e9\u671f\u7684\u6301\u7eed\u6027\u6d3b\u52a8\u3002\u5b83\u9700\u8981\u5229\u7528\u4ea7\u54c1\u53ca\u5176\u5e94\u7528\u4ee5\u53ca\u4e34\u5e8a\u548c\u975e\u4e34\u5e8a\u6570\u636e\u7b49\u4e00\u822c\u77e5\u8bc6\u3002\u5728\u4ea7\u54c1\u5f00\u53d1\u7684\u521d\u671f\uff0cCQAs \u662f\u6613\u53d8\u7684\uff0c\u6240\u4ee5\u9700\u8981\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u65b9\u6cd5\u6765\u8f6c\u5316\u4ea7\u751f\u7684\u4ea7\u54c1\u548c\u5de5\u827a\u7684\u77e5\u8bc6\uff08\u6709\u5173\u8ba8\u8bba\u89c16.1 \u8282\u201c\u98ce\u9669\u7ba1\u7406\u7684\u5e94\u7528\u201d\uff09\u3002\u5546\u4e1a\u4ea7\u54c1\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u5e94\u5728\u7b2c\u4e8c\u9636\u6bb5\u6d3b\u52a8\u5f00\u59cb\u524d\u88ab\u5b9a\u4e49\u3002<\/span><\/p>\n<p><br  \/><\/p>\n<h2 class=\"rich_media_title\" style=\"\" sans=\"sans\" gb=\"gb\" yahei=\"yahei\" none=\"none\" px=\"px\" normal=\"normal\" neue=\"neue\" sc=\"sc\" ui=\"ui\" helvetica=\"helvetica\" center=\"center\" rgb=\"rgb\"><span style=\"color: rgb(255, 0, 0);font-size: 16px;\">PDA TR60 \u98ce\u9669\u8bc4\u4f30\u548c\u53c2\u6570\u5173\u952e\u6027\u8bbe\u5b9a<\/span><\/h2>\n<p><br  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Risk Assessment and Parameter Criticality Designation<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u98ce\u9669\u8bc4\u4f30\u548c\u53c2\u6570\u5173\u952e\u6027\u8bbe\u5b9a<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Risk assessment plays an important role in the development of a commercial control strategy. Risk assessments are performed by interdisciplinary teams at several points during stage 1 of the lifecycle, and serve a number of purposes. (See Section 6.1 \u2013 Application of Risk Management) Risk assessment tools<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">provide a structured means for documenting data and rationale associated with the risk assessment outcome, and becomes part of the documented process development history.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u98ce\u9669\u8bc4\u4f30\u5728\u5546\u4e1a\u5316\u63a7\u5236\u7b56\u7565\u5f00\u53d1\u4e2d\u5177\u6709\u91cd\u8981\u4f5c\u7528\u3002\u98ce\u9669\u8bc4\u4f30\u662f\u5728\u751f\u547d\u5468\u671f\u7b2c\u4e00\u9636\u6bb5\u7684\u51e0\u4e2a\u70b9\u4e0a\u7531\u8de8\u5b66\u79d1\u56e2\u961f\u5b9e\u65bd\u7684\uff0c\u5206\u5c5e\u4e8e\u4e0d\u540c\u76ee\u6807\u3002\uff08\u89c1\u7b2c6.1\u8282\u98ce\u9669\u7ba1\u7406\u7684\u5e94\u7528\uff09\u98ce\u9669\u8bc4\u4f30\u5de5\u5177\u63d0\u4f9b\u4e86\u4e00\u4e2a\u7ed3\u6784\u5316\u7684\u65b9\u5f0f\u6765\u8bb0\u5f55\u4e0e\u98ce\u9669\u8bc4\u4f30\u7684\u7ed3\u679c\u76f8\u5173\u7684\u6570\u636e\u548c\u7406\u7531\uff0c\u5e76\u6210\u4e3a\u5de5\u827a\u5f00\u53d1\u5386\u53f2\u8bb0\u5f55\u7684\u4e00\u90e8\u5206\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">As shown in Figure 3.0-1, the initial identification of critical quality attributes is followed by a quality risk assessment in stage 1. The initial quality risk assessment is a cause and effect type of analysis to identify process input parameters where variability is likely to have the greatest impact to product quality or process performance. This assessment is based primarily on prior knowledge or early development work, and the outcome of this assessment provides the foundation for process characterization studies that follow.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u5982\u56fe3.0-1\u6240\u793a\uff0c\u5728\u7b2c\u4e00\u9636\u6bb5\u901a\u8fc7\u8d28\u91cf\u98ce\u9669\u8bc4\u4f30\u521d\u6b65\u8bc6\u522b\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u3002\u521d\u59cb\u8d28\u91cf\u98ce\u9669\u8bc4\u4f30\u662f\u8bc6\u522b\u5bf9\u4ea7\u54c1\u8d28\u91cf\u6216\u5de5\u827a\u6027\u80fd\u5f71\u54cd\u6700\u5927\u7684\u5de5\u827a\u8f93\u5165\u53c2\u6570\u53d8\u91cf\u7684\u539f\u56e0\u548c\u5f71\u54cd\u5206\u7c7b\u3002\u8fd9\u4e2a\u8bc4\u4f30\u4e3b\u8981\u662f\u57fa\u4e8e\u5df2\u6709\u77e5\u8bc6\u6216\u65e9\u671f\u5f00\u53d1\u5de5\u4f5c\uff0c\u8bc4\u4f30\u7ed3\u679c\u4e3a\u4e0b\u8ff0\u5de5\u827a\u6027\u80fd\u7814\u7a76\u63d0\u4f9b\u57fa\u7840\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Understanding the impact of process parameter variability and applying the appropriate controls is a fundamental element in development of the commercial control strategy. ICH Q8 (R2) defines a Critical Process Parameter (CPP) as, \u201cone with variability that has an impact on a CQA, and therefore, should be monitored or controlled to ensure that the process produces the desired quality (3).<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u4e86\u89e3\u5de5\u827a\u53c2\u6570\u53d8\u5316\u7684\u5f71\u54cd\u548c\u5e94\u7528\u9002\u5f53\u7684\u63a7\u5236\u662f\u5546\u4e1a\u5316\u63a7\u5236\u7b56\u7565\u5f00\u53d1\u7684\u57fa\u672c\u8981\u7d20\u3002ICH Q8 (R2)\u5b9a\u4e49\u5173\u952e\u5de5\u827a\u53c2\u6570\uff08CPP\uff09\u4e3a\uff1a\u201c\u5bf9CQA\u6709\u5f71\u54cd\u7684\u53ef\u53d8\u53c2\u6570\uff0c\u56e0\u6b64\uff0c\u5e94\u8be5\u88ab\u76d1\u6d4b\u6216\u63a7\u5236\u4ee5\u4fdd\u8bc1\u8be5\u5de5\u827a\u4ea7\u751f\u9884\u671f\u7684\u8d28\u91cf\u201d\uff083\uff09\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Process parameters may be further categorized based on impact to the process. In certain circumstances, process performance is controlled and monitored as an additional means of ensuring a consistent state of<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">control. Process parameters that have been shown experimentally to impact process performance may be classified as key process parameters (KPP). KPPs may impact process performance attributes (such antibody titer in cell culture processes or yield in downstream purification), but do not impact critical product quality attributes (15). In some processes, identifying and appropriately controlling KPPs is useful since process performance measures may be an important means of demonstrating intra-batch consistency.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u6839\u636e\u5bf9\u5de5\u827a\u7684\u5f71\u54cd\uff0c\u5de5\u827a\u53c2\u6570\u53ef\u4ee5\u88ab\u8fdb\u4e00\u6b65\u5206\u7c7b\u3002\u5728\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u5de5\u827a\u6027\u80fd\u7684\u63a7\u5236\u548c\u76d1\u63a7\u662f\u4f5c\u4e3a\u4e00\u4e2a\u989d\u5916\u7684\u63a7\u5236\u624b\u6bb5\uff0c\u786e\u4fdd\u63a7\u5236\u72b6\u6001\u7684\u534f\u8c03\u4e00\u81f4\u3002\u8bd5\u9a8c\u663e\u793a\u5bf9\u5de5\u827a\u6027\u80fd\u6709\u5f71\u54cd\u7684\u5de5\u827a\u53c2\u6570\u53ef\u4ee5\u5206\u7c7b\u4e3a\u91cd\u8981\u5de5\u827a\u53c2\u6570\uff08KPP\uff09\u3002KPPs\u53ef\u4ee5\u5f71\u54cd\u5de5\u827a\u6027\u80fd\u5c5e\u6027\uff08\u5982\u5728\u7ec6\u80de\u57f9\u517b\u8fc7\u7a0b\u4e2d\u7684\u6297\u4f53\u6ef4\u5ea6\u6216\u4e0b\u6e38\u7eaf\u5316\u4ea7\u91cf\uff09\uff0c\u4f46\u4e0d\u5f71\u54cd\u4ea7\u54c1\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff0815\uff09\u3002\u5728\u6709\u4e9b\u5de5\u827a\u4e2d\uff0cKPPs\u7684\u8bc6\u522b\u548c\u9002\u5f53\u63a7\u5236\u662f\u6709\u7528\u7684\uff0c\u56e0\u4e3a\u5de5\u827a\u6027\u80fd\u8bc4\u4f30\u53ef\u80fd\u662f\u6279\u5185\u4e00\u81f4\u6027\u8bc1\u660e\u7684\u4e00\u4e2a\u91cd\u8981\u624b\u6bb5\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Beyond the generally recognized definition of a critical process parameter from of ICH Q8 (R2),however, process parameter designations are not standardized and approaches may vary. For this reason, definitions for parameter designations must be clearly documented and understood within the organization. Definitions should remain consistent throughout the process validation lifecycle.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u7136\u800c\uff0c\u9664\u4e86\u666e\u904d\u8ba4\u53ef\u7684\u5b9a\u4e49ICH Q8\uff08R2\uff09\u7684\u5173\u952e\u5de5\u827a\u53c2\u6570\uff0c\u5de5\u827a\u53c2\u6570\u547d\u540d\u4f1a\u4e0d\u89c4\u8303\u3001\u65b9\u6cd5\u53ef\u80fd\u4f1a\u6709\u6240\u4e0d\u540c\u3002\u51fa\u4e8e\u8fd9\u4e2a\u539f\u56e0\uff0c\u5728\u7ec4\u7ec7\u5185\u53c2\u6570\u547d\u540d\u7684\u5b9a\u4e49\u5fc5\u987b\u6e05\u695a\u5730\u8bb0\u5f55\u5e76\u7406\u89e3\u3002\u5728\u6574\u4e2a\u5de5\u827a\u9a8c\u8bc1\u751f\u547d\u5468\u671f\u4e2d\u53c2\u6570\u547d\u540d\u7684\u5b9a\u4e49\u5e94\u4fdd\u6301\u4e00\u81f4\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Figure 3.6-1 provides an example of a decision tree developed to guide the assignment of parameter designations in conjunction with the quality risk assessments. The decision tree facilitates categorization of process parameters as critical, key, or non-key (see definitions). Decision making tools can facilitate common understanding among participants, and have the advantage increases consistency in the decision making process as well as consistent documentation of rationales as part of the risk assessment process.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u56fe3.6-1\u63d0\u4f9b\u4e86\u4e00\u4e2a\u51b3\u7b56\u6811\u793a\u4f8b\uff0c\u4ee5\u6307\u5bfc\u7ed3\u5408\u8d28\u91cf\u98ce\u9669\u8bc4\u4f30\u8fdb\u884c\u53c2\u6570\u547d\u540d\u3002\u51b3\u7b56\u6811\u6709\u52a9\u4e8e\u5c06\u5de5\u827a\u53c2\u6570\u5206\u7c7b\u4e3a\u5173\u952e\u3001\u91cd\u8981\u6216\u975e\u91cd\u8981\uff08\u89c1\u5b9a\u4e49\uff09\u3002\u51b3\u7b56\u5236\u5b9a\u5de5\u5177\u53ef\u4ee5\u5e2e\u52a9\u53c2\u4e0e\u8005\u5f62\u6210\u5171\u8bc6\uff0c\u5e76\u6709\u5229\u4e8e\u63d0\u9ad8\u51b3\u7b56\u8fc7\u7a0b\u7684\u4e00\u81f4\u6027\uff0c\u4ee5\u53ca\u4f5c\u4e3a\u98ce\u9669\u8bc4\u4f30\u8fc7\u7a0b\u90e8\u5206\u6709\u7406\u7531\u4e00\u81f4\u7684\u8bb0\u5f55\u6587\u6863\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">The decision tree can be used for risk assessments both before and after the supporting data from process characterizations studies are available.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u51b3\u7b56\u6811\u53ef\u4ee5\u7528\u4e8e\u6765\u6e90\u4e8e\u5de5\u827a\u6027\u80fd\u7814\u7a76\u7684\u652f\u6301\u6570\u636e\u524d\u540e\u7684\u98ce\u9669\u8bc4\u4f30\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u2022 Parameter or Attribute: Process variables can be outputs from one unit operation and inputs to another.For a given unit operation, each variable is initially established as a parameter or an attribute on the basis of direct controllability<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u53c2\u6570\u6216\u5c5e\u6027\uff1a\u5de5\u827a\u53d8\u91cf\u53ef\u4ee5\u662f\u5355\u5143\u64cd\u4f5c\u7684\u8f93\u51fa\u548c\u5bf9\u53e6\u4e00\u5355\u5143\u7684\u8f93\u5165\u3002\u5bf9\u4e00\u4e2a\u6307\u5b9a\u7684\u5355\u5143\u64cd\u4f5c\uff0c\u6839\u636e\u6bcf\u4e2a\u53d8\u91cf\u7684\u76f4\u63a5\u53ef\u63a7\u6027\u521d\u6b65\u8bbe\u5b9a\u4e3a\u53c2\u6570\u6216\u5c5e\u6027\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Yes \u2014 Directly controllable process input parameters can theoretically contribute to process variability.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u662f\u2014\u76f4\u63a5\u53ef\u63a7\u7684\u5de5\u827a\u8f93\u5165\u53c2\u6570\u7406\u8bba\u4e0a\u6709\u5229\u4e8e\u5de5\u827a\u53d8\u5f02\u6027\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">No \u2014 Process outputs that are not directly controllable are attributes that are monitored and may be indicative of process performance or product quality.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u5426\u2014\u4e0d\u80fd\u76f4\u63a5\u63a7\u5236\u7684\u5de5\u827a\u8f93\u51fa\u662f\u88ab\u76d1\u6d4b\u7684\u5c5e\u6027\uff0c\u53ef\u80fd\u8868\u793a\u5de5\u827a\u6027\u80fd\u6216\u4ea7\u54c1\u8d28\u91cf\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u2022 Process Parameters: Potential impact to critical quality attributes.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u5de5\u827a\u53c2\u6570\uff1a\u5bf9\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u7684\u6f5c\u5728\u5f71\u54cd\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Yes \u2014 If impact is suspected, or if data show that variability in a parameter could impact a CQA, the parameter is designated as a CPP. Although a parameter may be initially classified as a CPP, data from robustness studies conducted during process characterization may show that CQAs are not impacted despite exaggerated variations in the parameter. In these cases, the second risk assessment serves to change the assessment to non-CPP.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u662f\u2014\u5982\u679c\u6000\u7591\u53c2\u6570\u7684\u53d8\u5316\u5bf9CQA\u6709\u5f71\u54cd\uff0c\u6216\u5982\u679c\u6570\u636e\u663e\u793a\u53ef\u80fd\u4f1a\u6709\u5f71\u54cd\uff0c\u5219\u6307\u5b9a\u8fd9\u4e2a\u53c2\u6570\u4e3a\u5173\u952e\u5de5\u827a\u53c2\u6570\uff08CPP\uff09\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">No \u2014 Parameter is a non-CPP and is further evaluated<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u5426\u2014\u53c2\u6570\u4e3a\u975e\u5173\u952e\u5de5\u827a\u53c2\u6570\u5e76\u8fdb\u4e00\u6b65\u8bc4\u4ef7\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u2022 Non-CPP: Potential to impact process performance or consistency if run outside of defined range.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u975e\u5173\u952e\u5de5\u827a\u53c2\u6570\uff1a\u5982\u679c\u8d85\u5b9a\u4e49\u8303\u56f4\u8fd0\u884c\uff0c\u6f5c\u5728\u5f71\u54cd\u5de5\u827a\u6027\u80fd\u6216\u7a33\u5b9a\u6027\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Yes \u2014 Parameter designated a KPP<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u662f\u2014\u53c2\u6570\u6307\u5b9a\u4e3a\u91cd\u8981\u5de5\u827a\u53c2\u6570\uff08KPP\uff09\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">No \u2014 Parameter has little impact to the process over a wide range. Parameter is designated a non-KPP.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u5426\u2014\u5728\u8f83\u5bbd\u7684\u8303\u56f4\u53c2\u6570\u5bf9\u5de5\u827a\u65e0\u5f71\u54cd\u3002\u53c2\u6570\u88ab\u6307\u5b9a\u4e3a\u975e\u91cd\u8981\u5de5\u827a\u53c2\u6570\uff08non-KPP\uff09\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Figure 3.6-1 Decision Tree for Designating Parameter Criticality<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u5173\u952e\u6027\u547d\u540d\u51b3\u7b56\u6811<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><img style=\"margin: 0px;padding: 0px;height: auto !important;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;width: auto !important;visibility: visible !important;\"      src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/07\/beepress1-1532923860.jpg\" alt=\"PDA\u53d1\u5e03\u300a\u6570\u636e\u5b8c\u6574\u6027\u68c0\u67e5\u5e94\u5bf9\u6307\u5357\u300b\" title=\"PDA\u53d1\u5e03\u300a\u6570\u636e\u5b8c\u6574\u6027\u68c0\u67e5\u5e94\u5bf9\u6307\u5357\u300b\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><br  \/><\/p>\n<\/p>\n<p><br  \/><\/p>\n<h2 class=\"rich_media_title\" style=\"\" sans=\"sans\" gb=\"gb\" yahei=\"yahei\" none=\"none\" px=\"px\" normal=\"normal\" neue=\"neue\" sc=\"sc\" ui=\"ui\" helvetica=\"helvetica\" center=\"center\" rgb=\"rgb\"><span style=\"font-size: 16px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"background-position: initial;margin: 0px;padding: 0px;background-image: initial;color: rgb(255, 41, 65);font-family: \u5b8b\u4f53;font-size: 16px;background-repeat: initial;background-attachment: initial;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;background-size: initial;\">PDA TR60\u4e2d\u5bf9\u5de5\u827a\u8868\u5f81\u7684\u63cf\u8ff0<\/span><\/strong><\/span><\/h2>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Process Characterization<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u5de5\u827a\u7279\u5f81\u63cf\u8ff0<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Process characterization is a set of documented studies in which operational parameters are purposely varied to determine their effect on product quality attributes and process performance. The approach uses the knowledge and information from the risk assessments to determine a set of process characterization studies to examine proposed ranges and interactions for process parameters. The resulting information is used to define the PPQ ranges and acceptance criteria. It can also be used to set the final parameter ranges and can be used to develop a Design Space if using an enhanced approach, i.e., incorporating advanced analytical and\/or manufacturing control technologies, to process development. Experiments can be designed to examine proposed ranges and explore ones wider than those that will normally be used in operation. An element of process characterization may include multivariate designed experiments to define process design space. While univariate approaches are appropriate for some variables to establish a proven acceptable range (PAR), multivariate studies account for interactions between process parameters\/material attributes (1).<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u5de5\u827a\u8868\u5f81\u662f\u4e00\u5957\u6587\u6863\u8bc1\u660e\u7684\u7814\u7a76\uff0c\u5728\u8be5\u7814\u7a76\u4e2d\u64cd\u4f5c\u53c2\u6570\u88ab\u6545\u610f\u6539\u53d8\u4ee5\u786e\u5b9a\u5b83\u4eec\u5bf9\u4ea7\u54c1\u8d28\u91cf\u5c5e\u6027\u548c\u5de5\u827a\u6027\u80fd\u7684\u5f71\u54cd\u3002\u8be5\u65b9\u6cd5\u4f7f\u7528\u6765\u81ea\u4e8e\u98ce\u9669\u8bc4\u4f30\u7684\u77e5\u8bc6\u548c\u4fe1\u606f\u4ee5\u786e\u5b9a\u4e00\u5957\u5de5\u827a\u8868\u5f81\u7814\u7a76\u6765\u68c0\u9a8c\u5de5\u827a\u53c2\u6570\u63a8\u8350\u7684\u8303\u56f4\u53ca\u5176\u4ea4\u4e92\u4f5c\u7528\u3002\u5f97\u5230\u7684\u4fe1\u606f\u88ab\u7528\u4e8e\u786e\u5b9aPPQ\uff08\u5de5\u827a\u6027\u80fd\u786e\u8ba4\uff09\u8303\u56f4\u548c\u63a5\u53d7\u6807\u51c6\u3002\u5982\u679c\u662f\u7528\u4e00\u4e2a\u52a0\u5f3a\u7684\u65b9\u6cd5\u6765\u5f00\u53d1\u5de5\u827a\uff0c\u5b83\u4e5f\u80fd\u7528\u4e8e\u8bbe\u7f6e\u6700\u7ec8\u53c2\u6570\u8303\u56f4\u4ee5\u53ca\u88ab\u7528\u4e8e\u5f00\u53d1\u4e00\u4e2a\u8bbe\u8ba1\u7a7a\u95f4\uff0c\u4f8b\u5982\u6574\u5408\u5148\u8fdb\u7684\u5206\u6790\u548c\/\u6216\u751f\u4ea7\u63a7\u5236\u6280\u672f\u3002\u5b9e\u9a8c\u53ef\u4ee5\u88ab\u8bbe\u8ba1\u7528\u6765\u63a8\u8350\u7684\u8303\u56f4\u4ee5\u53ca\u63a2\u7d22\u4e00\u4e9b\u5c06\u7528\u4e8e\u6b63\u5e38\u8fd0\u884c\u66f4\u5bbd\u7684\u8303\u56f4\u3002\u5de5\u827a\u8868\u5f81\u7684\u4e00\u4e2a\u8981\u7d20\u53ef\u80fd\u5305\u62ec\u591a\u53d8\u91cf\u8bbe\u8ba1\u5b9e\u9a8c\u4ee5\u786e\u5b9a\u5de5\u827a\u8bbe\u8ba1\u7a7a\u95f4\u3002\u5f53\u5355\u53d8\u91cf\u7684\u65b9\u6cd5\u9002\u7528\u4e8e\u4e3a\u4e00\u4e9b\u53d8\u91cf\u53bb\u5efa\u7acb\u8bc1\u660e\u53ef\u63a5\u53d7\u7684\u8303\u56f4\u65f6\uff08PAR\uff09\uff0c\u591a\u53d8\u91cf\u7814\u7a76\u53ef\u4ee5\u5bf9\u5de5\u827a\u53c2\u6570\/\u7269\u6599\u5c5e\u6027\u95f4\u7684\u4ea4\u4e92\u4f5c\u7528\u7ed9\u51fa\u89e3\u91ca\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Since Studies designed to characterize the process and setting acceptable ranges for process parameters are usually performed at laboratory scale. The ability of laboratory-scale studies to predict process performance is desirable. When a laboratory scale model is used in development, the adequacy of the<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">model should be verified and justified. When there are differences between actual and expected performance, laboratory models and model predictions should be appropriately modified. In that the conclusions drawn from the studies are applied directly to the commercial-scale process, qualification of<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">laboratory-scale models is essential. Qualification of the scaled- down models should confirm that they perform in a manner that is representative of the full-scale process. This is shown by comparing operational parameters and inputs and outputs, including product quality attributes.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u7531\u4e8e\u8bbe\u8ba1\u7528\u6765\u8868\u5f81\u5de5\u827a\u548c\u4e3a\u5de5\u827a\u53c2\u6570\u8bbe\u7f6e\u53ef\u63a5\u53d7\u8303\u56f4\u7684\u7814\u7a76\u901a\u5e38\u5728\u5b9e\u9a8c\u5ba4\u89c4\u6a21\u8fdb\u884c\uff0c\u56e0\u6b64\u5b9e\u9a8c\u5ba4\u89c4\u6a21\u7814\u7a76\u9884\u6d4b\u5de5\u827a\u6027\u80fd\u7684\u80fd\u529b\u662f\u503c\u5f97\u671f\u5f85\u7684\u3002\u5f53\u4e00\u4e2a\u5b9e\u9a8c\u5ba4\u89c4\u6a21\u7684\u6a21\u578b\u88ab\u7528\u5728\u7814\u53d1\u4e2d\u65f6\uff0c\u8be5\u6a21\u578b\u7684\u5145\u5206\u6027\u5e94\u8be5\u88ab\u8bc1\u5b9e\u548c\u5408\u7406\u8bf4\u660e\u3002\u5f53\u5728\u5b9e\u9645\u548c\u671f\u671b\u7684\u6027\u80fd\u95f4\u6709\u5dee\u5f02\u65f6\uff0c\u5b9e\u9a8c\u5ba4\u6a21\u578b\u548c\u6a21\u578b\u9884\u6d4b\u6cd5\u5e94\u8be5\u9002\u5f53\u7ea0\u6b63\uff0c\u56e0\u4e3a\u4ece\u7814\u7a76\u4e2d\u5f97\u5230\u7684\u7ed3\u8bba\u88ab\u76f4\u63a5\u5e94\u7528\u5230\u5546\u4e1a\u89c4\u6a21\u5de5\u827a\u3002\u5b9e\u9a8c\u5ba4\u6a21\u578b\u7684\u786e\u8ba4\u662f\u5fc5\u4e0d\u53ef\u5c11\u7684\uff0c\u7f29\u5c0f\u6bd4\u4f8b\u7684\u6a21\u578b\u7684\u786e\u8ba4\u5e94\u8be5\u8bc1\u5b9e\u5b83\u4eec\u7684\u6027\u80fd\u4ee3\u8868\u5b9e\u9645\u7684\u751f\u4ea7\u89c4\u6a21\u5de5\u827a\uff0c\u8fd9\u901a\u8fc7\u6bd4\u8f83\u8fd0\u884c\u53c2\u6570\u548c\u8f93\u5165\u8f93\u51fa\uff0c\u5305\u62ec\u4ea7\u54c1\u8d28\u91cf\u5c5e\u6027\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Scaled-down models for chromatography steps for protein products can be qualified by performing multiple runs with input parameters at set points and comparing the results to the full-scale unit operation. Parameters evaluated should include those that affect process consistency, such as step yields, elution profile, elution volume, and\/or retention time. These should then be combined with those that represent product quality, such as pool purity and levels of process-related and host cell-related impurities.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u5bf9\u7528\u4e8e\u86cb\u767d\u4ea7\u54c1\u7684\u8272\u8c31\u5c42\u6790\u6b65\u9aa4\u7684\u7f29\u5c0f\u6bd4\u4f8b\u7684\u6a21\u578b\u80fd\u901a\u8fc7\u5728\u8bbe\u7f6e\u70b9\u8f93\u5165\u53c2\u6570\u6267\u884c\u591a\u6b21\u8fd0\u884c\u4ee5\u53ca\u6bd4\u8f83\u4e0e\u5b9e\u9645\u89c4\u6a21\u7684\u5355\u5143\u64cd\u4f5c\u95f4\u7684\u7ed3\u679c\u6765\u786e\u8ba4\u3002\u8bc4\u4ef7\u7684\u53c2\u6570\u5e94\u8be5\u5305\u62ec\u90a3\u4e9b\u5f71\u54cd\u5de5\u827a\u4e00\u81f4\u6027\uff0c\u8bf8\u5982\u5de5\u5e8f\u6536\u7387\u3001\u6d17\u8131\u56fe\u3001\u6d17\u8131\u4f53\u79ef\u548c\/\u6216\u4fdd\u7559\u65f6\u95f4\uff0c\u7136\u540e\u8fd9\u4e9b\u5e94\u8be5\u4e0e\u90a3\u4e9b\u4ee3\u8868\u4ea7\u54c1\u8d28\u91cf\u8bf8\u5982\u53ef\u601c\u7684\u7eaf\u5ea6\u548c\u5de5\u827a\u6709\u5173\u7684\u6c34\u5e73\u4ee5\u53ca\u4e0e\u5bbf\u4e3b\u7ec6\u80de\u6709\u5173\u7684\u6742\u8d28\u7ed3\u5408\u8d77\u6765\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Pilot-scale models of small molecules that are representative of the commercial manufacturing process may be used for supportive PPQ data. In solid and liquid oral dosage forms, 10% of the commercial batch size and\/or 100,000 units have been considered a representative scale (1). Scale-up effects for certain processes, such as mixing freely soluble substances, tablet compression, or liquid filling may be well-known. Batch sizes at 10% of bulk size or run times of 100,000 dosage units provide a sufficient duration to determine a degree of control and process characterization, while uncovering any preliminary major problems. Full-scale confirmation\/evaluation may be carried out when small-scale studies are used to support PPQ.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u4ee3\u8868\u5546\u4e1a\u751f\u4ea7\u5de5\u827a\u7684\u5c0f\u5206\u5b50\u4e2d\u8bd5\u89c4\u6a21\u6a21\u578b\u53ef\u80fd\u88ab\u7528\u4e8e\u652f\u6301PPQ\u6570\u636e\uff0c\u5728\u56fa\u4f53\u548c\u6db2\u4f53\u53e3\u670d\u5242\u578b\uff0c\u5546\u4e1a\u6279\u91cf\u768410%\u548c\/\u6216100000\u5355\u4f4d\u66fe\u88ab\u8003\u8651\u4e3a\u4e00\u4e2a\u4ee3\u8868\u6027\u89c4\u6a21\u3002\u67d0\u4e2a\u5de5\u827a\u7684\u653e\u5927\u7684\u6548\u679c\uff0c\u8bf8\u5982\u6df7\u5408\u6613\u6eb6\u89e3\u7269\u8d28\u3001\u836f\u7247\u538b\u7f29\u3001\u6216\u6db2\u4f53\u704c\u88c5\u53ef\u80fd\u4f17\u6240\u5468\u77e5\u3002\u5728\u539f\u6db210%\u7684\u6279\u91cf\u6216\u8fd0\u884c100000\u5242\u91cf\u5355\u4f4d\u7684\u500d\u6570\u63d0\u4f9b\u4e00\u4e2a\u5145\u5206\u6301\u7eed\u65f6\u95f4\u4ee5\u786e\u5b9a\u63a7\u5236\u7a0b\u5ea6\u548c\u5de5\u827a\u7279\u5f81\uff0c\u800c\u672a\u8986\u76d6\u4efb\u4f55\u521d\u6b65\u7684\u4e3b\u8981\u95ee\u9898\u3002\u5f53\u5c0f\u89c4\u6a21\u7814\u7a76\u88ab\u7528\u4e8e\u652f\u6301PPQ\u65f6\uff0c\u5b9e\u9645\u89c4\u6a21\u786e\u8ba4\/\u8bc4\u4f30\u53ef\u80fd\u88ab\u6267\u884c\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">For scale-down studies, the raw materials, component attributes, equipment, and process parameters should be comparable and indicative of the process intended for the commercial product.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u5bf9\u4e8e\u7f29\u5c0f\u6bd4\u4f8b\u7814\u7a76\uff0c\u5176\u539f\u6599\u3001\u7ec4\u4ef6\u5c5e\u6027\u3001\u8bbe\u5907\u4ee5\u53ca\u5de5\u827a\u53c2\u6570\u5e94\u8be5\u662f\u5177\u53ef\u6bd4\u6027\u548c\u80fd\u8868\u660e\u9884\u671f\u7528\u4e8e\u5546\u4e1a\u4ea7\u54c1\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">3.8 Product Characterization Testing Plan<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u4ea7\u54c1\u8868\u5f81\u6d4b\u8bd5\u8ba1\u5212<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">Some product characteristics may not be tested as part of the routine release test panel. Examples of such product characteristics include residual DNA levels for biotechnology products (when DNA clearance has been established at a level that clearly exceeds safety requirements) or final product porosity for solid oral dosage products (when dissolution testing is performed). In addition to release specifications, Stage 1 deliverables should include other tests on the DS, DP, or critical intermediates that are needed in order to claim a comprehensive understanding of the product and process.<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;line-height: 2em;background-color: rgb(255, 255, 255);\"><span style=\"font-size: 14px;\">\u4e00\u4e9b\u4ea7\u54c1\u8868\u5f81\u53ef\u80fd\u4f5c\u4e3a\u65e5\u5e38\u653e\u884c\u6d4b\u8bd5\u6807\u51c6\u7684\u4e00\u90e8\u5206\u800c\u4e0d\u5fc5\u6d4b\u8bd5\uff0c\u6b64\u7c7b\u4ea7\u54c1\u8868\u5f81\u4f8b\u5b50\u5305\u62ec\u751f\u7269\u6280\u672f\u4ea7\u54c1\u7684\u6b8b\u7559DNA\u6c34\u5e73\uff08\u5f53DNA\u6e05\u9664\u7387\u5df2\u7ecf\u5efa\u7acb\u5728\u4e00\u4e2a\u80fd\u6e05\u6670\u8d85\u51fa\u5b89\u5168\u8981\u6c42\u7684\u6c34\u5e73\u65f6\uff09\u6216\u56fa\u4f53\u53e3\u670d\u5236\u5242\u7684\u6700\u7ec8\u4ea7\u54c1\u7684\u591a\u5b54\u6027\uff08\u5f53\u6267\u884c\u6eb6\u89e3\u5ea6\u6d4b\u8bd5\u65f6\uff09\uff0c\u9664\u4e86\u653e\u884c\u6807\u51c6\uff0c\u9636\u6bb51\u53ef\u4ea4\u4ed8\u7684\u6210\u679c\u5e94\u8be5\u5305\u62ec\u5176\u5b83\u5bf9DS\u3001DP\u6216\u5173\u952e\u7684\u4e2d\u95f4\u4f53\u7684\u6d4b\u8bd5\u4e3a\u4e86\u8bf4\u660e\u5bf9\u4ea7\u54c1\u548c\u5de5\u827a\u7684\u5168\u9762\u7406\u89e3\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;text-indent: 27px;text-align: center;background-color: rgb(255, 255, 255);\"><br  \/><\/p>\n<p><span style=\"font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"background-position: initial;margin: 0px;padding: 0px;background-image: initial;color: rgb(255, 41, 65);font-family: \u5b8b\u4f53;font-size: 14px;background-repeat: initial;background-attachment: initial;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;background-size: initial;\">P<\/span><\/strong><\/span><span style=\"font-size: 16px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"background-position: initial;margin: 0px;padding: 0px;background-image: initial;color: rgb(255, 41, 65);font-family: \u5b8b\u4f53;background-repeat: initial;background-attachment: initial;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;background-size: initial;\">DA \u6280\u672f\u6307\u5357\u76ee\u5f55\u6536<\/span><\/strong><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"background-position: initial;margin: 0px;padding: 0px;background-image: initial;color: rgb(255, 41, 65);font-family: \u5b8b\u4f53;background-repeat: initial;background-attachment: initial;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;background-size: initial;\">\u96c6<\/span><\/strong><\/span><\/p>\n<p><br  \/><\/p>\n<p><br  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 01 -2007<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6e7f\u70ed\u706d\u83cc\u7684\u9a8c\u8bc1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u706d\u83cc\u7a0b\u5e8f\u7684\u8bbe\u8ba1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 03 -2013&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7528\u4e8e\u6740\u83cc\u548c\u9664\u70ed\u539f\u5e72\u70ed\u5de5\u827a\u7684\u9a8c\u8bc1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 04 -1983&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6ce8\u5c04\u7528\u6c34\u7684\u6982\u5ff5\u8bbe\u8ba1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 05 -1984&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u65e0\u83cc\u836f\u54c1\u5305\u88c5\uff1a\u517c\u5bb9\u6027\u548c\u7a33\u5b9a\u6027<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 07 -1985&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u70ed\u539f\u53bb\u9664<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 08 -1987&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6ce8\u5c04\u6eb6\u6db2\u6e7f\u70ed\u706d\u83cc\u7684\u53c2\u6570\u653e\u884c<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 09 -1988&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5546\u4e1a\u5316\u7c92\u5b50\u6d4b\u91cf\u7cfb\u7edf\u7684\u5ba1\u6838<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 10&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u86cb\u767d\u8d28\u548c\u591a\u80bd\u6ce8\u5c04\u5236\u5242\uff1a\u7a33\u5b9a\u6027\u548c\u7a33\u5b9a\u5242<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 11 -1988&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u03b3\u5c04\u7ebf\u706d\u83cc\u7684\u6ce8\u5c04\u5242<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 12 -1988<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5305\u88c5\u7ec4\u4ef6\u7684\u7845\u5316<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 13 -2013&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u73af\u5883\u76d1\u63a7\u8ba1\u5212\u57fa\u672c\u8981\u7d20<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 14 -2008&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u86cb\u767d\u7eaf\u5316\u5c42\u6790\u7cfb\u7edf\u9a8c\u8bc1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 15 -2009&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u751f\u7269\u5236\u836f\u5e94\u7528\u4e2d\u5207\u5411\u6d41\u8fc7\u6ee4\u7684\u9a8c\u8bc1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 16 -1992&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5f39\u6027\u5305\u88c5\u6750\u6599\u7684\u8f90\u5c04\u706d\u83cc<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-family: Simsun, serif;color: rgb(68, 68, 68);font-size: 14px;\">PDA TR 17Current Practices in theValidation of Aseptic Processing&nbsp;&nbsp;&nbsp;&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-family: Simsun, serif;color: rgb(68, 68, 68);font-size: 14px;\">PDA TR 18&nbsp;Reportonthe Validation of Computer-Related Systems<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-family: Simsun, serif;color: rgb(68, 68, 68);font-size: 14px;\">PDA TR 19Rapid\/Automated ID Methods Survey&nbsp; &nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-family: Simsun, serif;color: rgb(68, 68, 68);font-size: 14px;\">PDA TR 20&nbsp;ReportonSurvey of Current Industry Gowning Practices<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 21 -1990&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u751f\u7269\u8d1f\u8377\u91cf\u56de\u6536\u7387\u9a8c\u8bc1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 22 -2011&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u65e0\u83cc\u704c\u88c5\u4ea7\u54c1\u7684\u5de5\u827a\u6a21\u62df<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-family: Simsun, serif;color: rgb(68, 68, 68);font-size: 14px;\">PDA TR 23&nbsp;IndustrySurvey on Current Sterile Filtration Practices<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-family: Simsun, serif;color: rgb(68, 68, 68);font-size: 14px;\">PDA TR 24&nbsp;CurrentPractices in the Validation of Aseptic Processing<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 25&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6df7\u5408\u5747\u4e00\u6027\u5206\u6790\uff1a\u9a8c\u8bc1\u548c\u4e2d\u63a7\u6d4b\u8bd5<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 26 -2008&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u9664\u83cc\u8fc7\u6ee4\u9a8c\u8bc1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 27 -1998&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u836f\u54c1\u5305\u88c5\u7684\u5b8c\u6574\u6027<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 28 -2006&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u65e0\u83cc\u539f\u6599\u836f\u5de5\u827a\u6a21\u62df\u9a8c\u8bc1\uff08<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">EN<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\uff09<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 29 -2012&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6e05\u6d01\u9a8c\u8bc1\u8003\u8651\u8981\u70b9<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">(2013)&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 30 -1999&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u836f\u7269\u6700\u7ec8\u706d\u83cc\u7684\u6e7f\u70ed\u53c2\u6570\u653e\u884c<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 31 -1999&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u8ba1\u7b97\u673a\u5316\u5b9e\u9a8c\u5ba4\u6570\u636e\u6536\u96c6\u7cfb\u7edf\u9a8c\u8bc1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 32 -2004&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u8ba1\u7b97\u673a\u7cfb\u7edf\u4e0e\u670d\u52a1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 33 -2013&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u53ef\u9009\u62e9\u7684\u548c\u5feb\u901f\u7684\u5fae\u751f\u7269\u68c0\u6d4b\u65b9\u6cd5\u7684\u8bc4\u4ef7\u9a8c\u8bc1\u4e0e\u6267\u884c<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp; &nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 33 -2013&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u53ef\u9009\u62e9\u7684\u548c\u5feb\u901f\u7684\u5fae\u751f\u7269\u68c0\u6d4b\u65b9\u6cd5\u7684\u8bc4\u4ef7\u9a8c\u8bc1\u4e0e\u6267\u884c<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 34 -2001&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u536b\u751f\u4fdd\u5065\u4ea7\u54c1\u5236\u9020\u548c\u6d4b\u8bd5\u9694\u79bb\u7cfb\u7edf\u7684\u8bbe\u8ba1\u4e0e\u9a8c\u8bc1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 35 -2001&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u533b\u836f\u884c\u4e1a\u7684\u5fae\u751f\u7269\u4f5c\u7528\u5efa\u8bae\u7684\u57f9\u8bad\u6a21\u5f0f<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 36 -2001&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u65e0\u83cc\u5de5\u827a\u9a8c\u8bc1\u73b0\u884c\u60ef\u4f8b<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 38&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6279\u51c6\u540e\u751f\u4ea7\u7528\u8272\u8c31\u7cfb\u7edf\uff1a\u7814\u53d1\u3001\u751f\u4ea7\u548c\u63a7\u5236\u6587\u4ef6<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 39 -2007&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6e29\u5ea6\u53d7\u63a7\u836f\u54c1\u7684\u6307\u5bfc\u539f\u5219\uff1a\u5728\u8fd0\u8f93\u73af\u5883\u4e0b\u4fdd\u6301\u6e29\u5ea6\u654f\u611f\u4ea7\u54c1\u7684\u8d28\u91cf<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 40-2005&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6c14\u4f53\u65e0\u83cc\u8fc7\u6ee4<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 41&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u75c5\u6bd2\u8fc7\u6ee4<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 42 -2005&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u86cb\u767d\u751f\u4ea7\u9a8c\u8bc1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 43&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u836f\u7269\u751f\u4ea7\u7528\u6a21\u578b\u5236\u5907\u548c\u7ba1\u5f0f\u73bb\u7483\u5bb9\u5668\u7684\u8bc6\u522b\u548c\u5206\u7c7b<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 44 -2008&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u65e0\u83cc\u8fc7\u7a0b\u8d28\u91cf\u98ce\u9669\u7ba1\u7406<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 45-2007<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4f7f\u7528\u7ea4\u7ef4\u7d20\u57fa\u7840\u6df1\u5c42\u8fc7\u6ee4\u5668\u7684\u6db2\u4f53\u8fc7\u6ee4<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 46-2009&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6700\u7ec8\u91cc\u7a0b\uff1a\u7ed9\u6700\u7ec8\u7528\u6237\u7684\u836f\u7269\u4f18\u826f\u9500\u552e\u89c4\u8303\u6307\u5357<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp; &nbsp;&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 47-2010&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7528\u4e8e\u75c5\u6bd2\u6e05\u9664\u7814\u7a76\u7684\u75c5\u6bd2\u52a0\u6807\u6837\u5236\u5907<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 48-2010&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6e7f\u70ed\u706d\u83cc\u7cfb\u7edf\u7684\u8bbe\u8ba1\u3001\u8c03\u8bd5\u3001\u8fd0\u884c\u3001\u786e\u8ba4\u548c\u7ef4\u62a4<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 49 -2010&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u751f\u7269\u6280\u672f\u6e05\u6d01\u9a8c\u8bc1\u8003\u8651\u8981\u70b9<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 50- 2010&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u652f\u539f\u4f53\u68c0\u6d4b\u7684\u66ff\u4ee3\u65b9\u6cd5<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 51 -2010&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6c14\u4f53\u548c\u6c14\u76f8\u51c0\u5316\u5de5\u827a\u89c4\u8303\u3001\u5236\u9020\u3001\u63a7\u5236\u548c\u4f7f\u7528\u7684\u751f\u7269\u6307\u793a\u5242<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 52&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u836f\u54c1\u4f9b\u5e94\u94fe\u4f18\u826f\u9500\u552e\u89c4\u8303\u6307\u5357<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 53 -2011&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u884c\u4e1a\u6307\u5357\uff1a\u652f\u6301\u65b0\u836f\u9500\u552e\u7684\u7a33\u5b9a\u6027\u6d4b\u8bd5<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 54-1 2012<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u533b\u836f\u751f\u4ea7\u4e0e\u751f\u7269\u6280\u672f\u7684\u8d28\u91cf\u98ce\u9669\u7ba1\u7406<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 54-2 2013&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u9644\u5f55<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">1<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\uff1a\u5305\u88c5\u548c\u6807\u7b7e\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u6848\u4f8b\u7814\u7a76\u5b9e\u4f8b<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 54-3 2013&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u9644\u5f55<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">2<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\uff1a\u836f\u54c1\u836f\u54c1\u751f\u4ea7\u4e2d\u7684\u6848\u4f8b\u7814\u7a76<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 54-4 2014&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u9644\u5f55<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">3<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\uff1a\u751f\u7269\u6563\u88c5\u836f\u7528\u7269\u8d28\u751f\u4ea7\u4e2d\u7684\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u6848\u4f8b\u7814\u7a76<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 55&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u836f\u7269\u548c\u4fdd\u5065\u884c\u4e1a\u4e2d<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">2<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\uff0c<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">4<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\uff0c<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">6-<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4e09\u6eb4\u82ef\u7532\u919a\u548c<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">2<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\uff0c<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">4<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\uff0c<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">6-<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4e09\u6c2f\u82ef\u7532\u919a\u6c61\u67d3\u548c\u6c14\u5473\u7684\u68c0\u6d4b\u548c\u79fb\u9664<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 56&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6cbb\u7597\u7528\u86cb\u767d\u8d28\u836f\u7528\u7269\u8d28\u7814\u53d1\u4e2d\u4e0e\u9636\u6bb5\u76f8\u9002\u5f53\u7684\u8d28\u91cf\u4f53\u7cfb\u548c<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">C<span style=\"margin: 0px;padding: 0px;color: rgb(51, 102, 153);word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">GMP<\/span><\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5e94\u7528<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 57- 2012&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u751f\u7269\u6280\u672f\u4ea7\u54c1\u7684\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u548c\u8f6c\u79fb<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 58&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6e29\u5ea6\u53d7\u63a7\u9500\u552e\u98ce\u9669\u7ba1\u7406<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 59 -2012&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7edf\u8ba1\u65b9\u6cd5\u5728\u751f\u4ea7\u76d1\u63a7\u4e2d\u7684\u5e94\u7528<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 60 -2013&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5173\u4e8e\u5de5\u827a\u9a8c\u8bc1\u751f\u547d\u5468\u671f<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 61 -2013&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5728\u7ebf\u706d\u83cc<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 62 -2013&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4eba\u5de5\u65e0\u83cc\u5de5\u827a\u7684\u5efa\u8bae\u63aa\u65bd<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 63&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4e34\u5e8a\u8bd5\u9a8c\u4e34\u65f6\u5236\u5907\u836f\u7269\u7684\u8d28\u91cf\u8981\u6c42<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 64&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5728\u7528\u6e29\u5ea6\u63a7\u5236\u7cfb\u7edf\uff1a\u786e\u8ba4\u6307\u5357<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 65 -2014&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6280\u672f\u8f6c\u79fb<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 66 -2014&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u836f\u7269\u751f\u4ea7\u4e2d\u5355\u6b21\u4f7f\u7528\u7cfb\u7edf\u7684\u5e94\u7528<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 67 -2014&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u975e\u65e0\u83cc\u836f\u7269\u3001\u533b\u7597\u5668\u68b0\u548c\u5316\u5986\u54c1\u4e2d\u81f4\u75c5\u83cc\u6392\u9664<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 68 -2015&nbsp;<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u9884\u9632\u548c\u7ba1\u7406\u836f\u54c1\u77ed\u7f3a\u57fa\u4e8e\u98ce\u9669\u7684\u65b9\u6cd5<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp; &nbsp;<\/span><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 0.544000029563904px;orphans: auto;text-align: justify;text-indent: 0px;text-transform: none;white-space: normal;widows: 1;word-spacing: 0px;-webkit-text-stroke-width: 0px;color: rgb(62, 62, 62);font-size: 16px;line-height: 21px;background: white;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 69-<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u836f\u54c1\u5236\u9020\u4e2d\u751f\u7269\u8d1f\u8f7d\u548c\u751f\u7269\u819c\u5904\u7406<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;&nbsp;<\/span><\/span><\/p>\n<p style=\"background: white;\" sans=\"sans\" break-word=\"break-word\" important=\"important\" gb=\"gb\" yahei=\"yahei\" none=\"none\" px=\"px\" normal=\"normal\" em=\"em\" neue=\"neue\" sc=\"sc\" ui=\"ui\" helvetica=\"helvetica\" border-box=\"border-box\" rgb=\"rgb\" justify=\"justify\"><br  \/><\/p>\n<p><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PDA TR 70 -2015<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: \u5b8b\u4f53;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u65e0\u83cc\u5236\u9020\u8bbe\u65bd\u7684\u6e05\u6d01\u548c\u6d88\u6bd2\u7a0b\u5e8f\u7684\u57fa\u672c\u539f\u7406<\/span><span style=\"margin: 0px;padding: 0px;color: rgb(68, 68, 68);font-family: Simsun,serif;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">&nbsp;<\/span><\/span><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-family: Simsun, serif;color: rgb(68, 68, 68);\">&nbsp;<\/span><\/p>\n<section>\n<section class=\"cps_inner cps_inner_list js_list_container js_product_container cps_inner_book\">\n<div class=\"cps_inner_wrp js_product_loop_content\"        >\n<div class=\"cps_inner_content\">\n<figure class=\"cps_inner_image_container\">                                                        <\/figure>\n<div class=\"cps_inner_info\">\n<div class=\"cps_inner_info_hd\">\n<h2 class=\"cps_inner_info_title\">\u8ba9\u5b69\u5b50\u7231\u4e0a\u79d1\u5b66\u7684\u8da3\u5473\u5b9e\u9a8c\u5927\u767e\u79d1<\/h2>\n<p class=\"cps_inner_info_desc\">\u4f5c\u8005\uff1a[\u65e5]\u5b66\u7814\u6559\u80b2\u51fa\u7248\u3000\u7f16\uff0c\u6797\u5c9a\uff0c\u6797\u6995\u3000\u8bd1<\/p>\n<\/p><\/div>\n<div class=\"cps_inner_info_ft\">\n<div class=\"cps_inner_info_ft_left\">                                      <span class=\"cps_inner_info_from\">                                          <span   style=\"background: url(http:\/\/mmbiz.qpic.cn\/mmbiz_png\/6nVmK0mHaRr8fd8C4yNUm5BrcwmJ17I867w7sZwrxtAmG0NdTKhZj8eAEeRt0Ycgc9pnL4ib77PJ0UKDoT43MsA\/0) no-repeat center;                                          background-size: contain;\" class=\"cps_inner_ic_from\"><\/span>\u5f53\u5f53                                      <\/span>  \t\t\t\t\t\t\t\t\t                                    <span class=\"cps_inner_info_adTag js_cps_adTag\">\u5e7f\u544a<\/span>  \t\t\t\t\t\t\t\t\t                                <\/div>\n<p>                                  <span class=\"cps_inner_btn_cps_info\"><i class=\"cps_inner_ic_miniapp\"><\/i><span class='js_btn_word'>\u8d2d\u4e70<\/span><\/span>                              <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n<p><br  \/><\/p>\n<blockquote class='keep-source'>\n<p>\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a                         \u5236\u836f\u5de5\u7a0b\u8bba\u575b                      <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>2018\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7528\u4e662018\u897f\u836f \u56fd\u5bb6\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u540c\u6b65\u9898\u5e93 \u836f\u5b66\u4e13\u4e1a\u77e5\u8bc6\uff08\u4e8c\uff09\uff08\u7b2c\u4e8c\u7248\uff09 \u4f5c\u8005\uff1a\u56fd\u5bb6\u6267\u4e1a\u836f [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":12594,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/12593"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=12593"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/12593\/revisions"}],"predecessor-version":[{"id":12597,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/12593\/revisions\/12597"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/12594"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=12593"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=12593"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=12593"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}