{"id":12614,"date":"2018-07-18T01:00:00","date_gmt":"2018-07-30T04:11:12","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/30\/pic-s%e6%9c%89%e6%9b%b4%e6%96%b0%e5%95%a6%ef%bc%81\/"},"modified":"2018-07-30T12:11:13","modified_gmt":"2018-07-30T04:11:13","slug":"pic-s%e6%9c%89%e6%9b%b4%e6%96%b0%e5%95%a6%ef%bc%81","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/12614\/","title":{"rendered":"PIC\/S\u6709\u66f4\u65b0\u5566\uff01"},"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\">\u667a\u80fd\u65f6\u4ee3\uff1a\u5927\u6570\u636e\u4e0e\u667a\u80fd\u9769\u547d\u91cd\u65b0\u5b9a\u4e49\u672a\u6765<\/h2>\n<p class=\"cps_inner_info_desc\">\u4f5c\u8005\uff1a\u5434\u519b<\/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 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: 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border-box;word-wrap: break-word !important;clear: both;min-height: 1em;white-space: normal;\"><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;white-space: normal;\">\u76ee\u524d\u8fd9\u4e9b\u6587\u4ef6\u5747\u5728\u9646\u7eed\u7ffb\u8bd1\u4e2d\u3002\u4ee5\u4e0b\u4e3a\u5173\u4e8e\u786e\u5b9a\u7528\u4e8e\u4eba\u7528\u836f\u6240\u7528\u8f85\u6599\u7684GMP\u6c34\u5e73\u786e\u5b9a\u7528\u6b63\u5f0f\u98ce\u9669\u8bc4\u4f30\u6307\u5357\uff08PI 045-1\uff09\u4e2d\u82f1\u5bf9\u7167\u6587\u4ef6\u3002<\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;text-align: center;font-size: 16px;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">GUIDELINES&nbsp;ON&nbsp;THE&nbsp;FORMALISED&nbsp;RISK&nbsp;ASSESSMENT&nbsp;FOR&nbsp;ASCERTAINING&nbsp;THE&nbsp;APPROPRIATE&nbsp;GOOD&nbsp;MANUFACTURING&nbsp;PRACTICE&nbsp;FOR&nbsp;EXCIPIENTS&nbsp;OF&nbsp;MEDICINAL&nbsp;PRODUCTS&nbsp;FOR&nbsp;HUMAN&nbsp;USE<\/strong><\/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;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/strong><\/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;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\u4eba\u7528\u836f\u6240\u7528\u8f85\u6599\u7684GMP\u6c34\u5e73\u786e\u5b9a\u7528\u6b63\u5f0f\u98ce\u9669\u8bc4\u4f30<\/strong><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;line-height: 1.6;\">\u6307\u5357<\/strong><\/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<\/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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;text-align: center;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">TABLE OF CONTENTS<\/strong><\/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;text-align: center;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\u76ee\u5f55<\/strong><\/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;\">&nbsp;<\/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;\">Section 1.&nbsp;Document&nbsp;history&nbsp;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(160, 160, 160);\">\u6587\u4ef6\u8bb0\u5f55<\/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;\">Section 2.&nbsp;Introduction&nbsp;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(160, 160, 160);\">\u4ecb\u7ecd<\/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;\">Section&nbsp;3.&nbsp;Scope&nbsp;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(160, 160, 160);\">\u8303\u56f4<\/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;\">Section&nbsp;4.&nbsp;Determination of&nbsp;appropriate GMP based on&nbsp;type&nbsp;and use of&nbsp;excipient&nbsp;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(160, 160, 160);\">\u57fa\u4e8e\u8f85\u6599\u7c7b\u578b\u548c\u7528\u9014\u7684\u9002\u5f53\u7684GMP\u51b3\u7b56<\/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;\">Section&nbsp;5.&nbsp;Determinationof&nbsp;excipient&nbsp;manufacturer\u2019s&nbsp;risk&nbsp;profile&nbsp;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(160, 160, 160);\">\u786e\u5b9a\u8f85\u6599\u751f\u4ea7\u7684\u98ce\u9669\u6982\u51b5<\/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;\">Section&nbsp;6.&nbsp;Confirmation of&nbsp;application of&nbsp;appropriate&nbsp;GMP&nbsp;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(160, 160, 160);\">\u9002\u5f53GMP\u7533\u8bf7\u786e\u8ba4<\/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;\">Section&nbsp;7.&nbsp;Revision History&nbsp;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(160, 160, 160);\">\u4fee\u8ba2\u8bb0\u5f55&nbsp;<\/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<\/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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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 0px 3px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;vertical-align: middle;border-bottom-width: 3px;border-bottom-style: solid;border-color: rgb(0, 110, 189);\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;border-bottom-width: 1px;border-bottom-style: solid;border-color: rgb(0, 110, 189);\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">1.&nbsp;DOCUMENT&nbsp;HISTORY &nbsp;&nbsp;&nbsp;&nbsp;\u6587\u4ef6\u8bb0\u5f55<\/strong><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;color: rgb(255, 129, 36);\">\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<\/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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\"><\/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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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 0px 3px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;vertical-align: middle;border-bottom-width: 3px;border-bottom-style: solid;border-color: rgb(0, 110, 189);\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;border-bottom-width: 1px;border-bottom-style: solid;border-color: rgb(0, 110, 189);\">\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;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">2.&nbsp;INTRODUCTION &nbsp;&nbsp;&nbsp;\u4ecb\u7ecd<\/strong><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\"><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;\">The present PIC\/S Guidelines are based on EC document 2015\/C 95\/02, which has been drafted by the EMA GMDP IWG and transposed for PIC\/S purpose by the PIC\/S Sub-Committee on the Harmonisation of GM(D)P.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u672cPIC \/ S\u6307\u5357\u662f\u57fa\u4e8eEC\u6587\u4ef62015 \/ C 95\/02\uff0c\u7531EMA GMDP IWG\u8d77\u8349\u3001\u7531PIC \/ S\u5c0f\u7ec4\u59d4\u5458\u4f1a\u534f\u8c03GM\uff08D\uff09P\u7684PIC\/S\u7528\u9014\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;\">&nbsp;<\/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;\">These guidelines have been adopted by PIC\/S as a guidance document. It is up to each PIC\/S Participating Authority to decide whether it should become a legally- binding standard.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8fd9\u4e9b\u51c6\u5219\u5df2\u88abPIC \/ S\u4f5c\u4e3a\u6307\u5bfc\u6027\u6587\u4ef6\u3002\u7531\u6bcf\u4e2aPIC \/ S\u53c2\u4e0e\u673a\u6784\u51b3\u5b9a\u662f\u5426\u5e94\u6210\u4e3a\u5177\u6709\u6cd5\u5f8b\u7ea6\u675f\u529b\u7684\u6807\u51c6\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;\">&nbsp;<\/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;\">The manufacturing authorisation holder is required to ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice (GMP) is. The appropriate GMP for excipients of medicinal products for human use shall be ascertained on the basis of a formalised risk assessment in accordance with these guidelines. The risk assessment shall take into account requirements under other appropriate quality systems as well as the source and intended use of the excipients and previous instances of quality defects. The manufacturing authorisation holder shall ensure that the appropriate GMP ascertained is applied. The manufacturing authorisation holder shall document the measures taken.<\/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;text-align: justify;white-space: normal;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u751f\u4ea7\u8bb8\u53ef\u6301\u6709\u4eba\u5e94\u901a\u8fc7\u786e\u8ba4\u9002\u5f53\u7684GMP\u4fdd\u8bc1\u8f85\u6599\u9002\u7528\u4e8e\u5728\u836f\u54c1\u4e2d\u7684\u7528\u9014\u3002\u4eba\u836f\u7528\u836f\u8f85\u6599\u9002\u5f53\u7684GMP\u5e94\u6839\u636e\u8fd9\u4e9b\u6307\u5357\uff0c\u57fa\u4e8e\u6b63\u5f0f\u7684\u98ce\u9669\u8bc4\u4f30\u8fdb\u884c\u786e\u5b9a\u3002\u98ce\u9669\u8bc4\u4f30\u5e94\u8003\u8651\u5176\u4ed6\u9002\u5f53\u8d28\u91cf\u4f53\u7cfb\u7684\u8981\u6c42\uff0c\u4ee5\u53ca\u8f85\u6599\u7684\u6765\u6e90\u548c\u7528\u9014\uff0c\u4ee5\u53ca\u4e4b\u524d\u7684\u8d28\u91cf\u7f3a\u9677\u60c5\u51b5\u3002&nbsp;\u751f\u4ea7\u8bb8\u53ef\u6301\u6709\u4eba\u5e94\u4fdd\u8bc1\u6240\u786e\u5b9a\u7684GMP\u662f\u9002\u7528\u7684\u3002\u751f\u4ea7\u8bb8\u53ef\u6301\u6709\u4eba\u5e94\u8bb0\u5f55\u6240\u91c7\u53d6\u7684\u63aa\u65bd\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;text-align: justify;white-space: normal;\">&nbsp;<\/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;\">The&nbsp;excipient&nbsp;risk&nbsp;assessment\/risk&nbsp;management&nbsp;procedure&nbsp;should&nbsp;be&nbsp;incorporated in&nbsp;the&nbsp;pharmaceutical&nbsp;quality&nbsp;system of&nbsp;the&nbsp;manufacturing&nbsp;authorisation&nbsp;holder.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8f85\u6599\u98ce\u9669\u8bc4\u4f30\/\u98ce\u9669\u7ba1\u7406\u7a0b\u5e8f\u5e94\u7ed3\u5408\u751f\u4ea7\u8bb8\u53ef\u6301\u6709\u4eba\u7684\u836f\u54c1\u8d28\u91cf\u4f53\u7cfb\u4e2d\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;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/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;\">Manufacturing authorisation holders should have the risk assessment\/management documentation for appropriate GMP for excipients available on site for review by GMP inspectors. Consideration should be given to sharing relevant information from the risk assessment with the excipient manufacturer to facilitate continuous improvement.<\/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;text-align: justify;white-space: normal;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u751f\u4ea7\u8bb8\u53ef\u6301\u6709\u4eba\u5e94\u9488\u5bf9\u8f85\u6599\u6240\u7528\u7684\u9002\u5f53\u7684GMP\u8981\u6c42\u7684\u98ce\u9669\u8bc4\u4f30\/\u7ba1\u7406\u6587\u4ef6\u8bb0\u5f55\uff0c\u5e76\u80fd\u63d0\u4f9b\u7ed9GMP\u68c0\u67e5\u5458\u68c0\u67e5\u3002&nbsp;\u5e94\u8003\u8651\u4e0e\u8f85\u6599\u751f\u4ea7\u5546\u5171\u4eab\u98ce\u9669\u8bc4\u4f30\u6240\u4ea7\u751f\u7684\u76f8\u5173\u4fe1\u606f\uff0c\u4ee5\u4fc3\u8fdb\u6301\u7eed\u6539\u8fdb\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;\">&nbsp;<\/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;\">A risk assessment as set out in these guidelines should be carried out for excipients for authorised medicinal products for human use in accordance with provisions established by applicable national competent authorities.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u6839\u636e\u56fd\u5bb6\u6709\u5173\u4e3b\u7ba1\u90e8\u95e8\u7684\u89c4\u5b9a\uff0c\u5e94\u5bf9\u4eba\u7528\u836f\u54c1\u4e2d\u8f85\u6599\u5c31\u8fd9\u4e9b\u5217\u51fa\u7684\u6307\u5357\u8fdb\u884c\u98ce\u9669\u8bc4\u4f30\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;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">&nbsp;<\/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<\/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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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 0px 3px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;vertical-align: middle;border-bottom-width: 3px;border-bottom-style: solid;border-color: rgb(0, 110, 189);\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;border-bottom-width: 1px;border-bottom-style: solid;border-color: rgb(0, 110, 189);\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">3.&nbsp;SCOPE &nbsp;&nbsp;&nbsp;\u8303\u56f4<\/strong><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;color: rgb(255, 129, 36);\">\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<\/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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;text-align: justify;\">3.1&nbsp;These&nbsp;guidelines&nbsp;apply&nbsp;to&nbsp;the&nbsp;risk&nbsp;assessment&nbsp;for&nbsp;ascertaining&nbsp;the appropriate&nbsp;GMP&nbsp;for&nbsp;excipients&nbsp;for&nbsp;medicinal&nbsp;products&nbsp;for&nbsp;human&nbsp;use.&nbsp;An excipient&nbsp;is&nbsp;any&nbsp;constituent&nbsp;of&nbsp;a&nbsp;medicinal&nbsp;product&nbsp;other&nbsp;than&nbsp;the&nbsp;active substance&nbsp;and&nbsp;the&nbsp;packaging&nbsp;material<\/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;\">&nbsp;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8fd9\u4e9b\u6307\u5357\u9002\u7528\u4e8e\u98ce\u9669\u8bc4\u4f30\uff0c\u6765\u8bc4\u4ef7\u5e94\u7528\u9002\u5f53\u7684GMP\u4e8e\u4eba\u7528\u836f\u6240\u7528\u8f85\u6599\u7ba1\u7406\u3002&nbsp;\u8f85\u6599\u662f\u836f\u54c1\u4e2d\u4e0d\u5305\u62ec\u6d3b\u6027\u6210\u5206\u548c\u5305\u88c5\u6750\u6599\u5728\u5185\u7684\u5176\u5b83\u7ec4\u6210\u90e8\u5206\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;\">&nbsp;<\/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;\">&nbsp;<\/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;\">3.2 These guidelines do not cover substances added to stabilise active substances that cannot exist on their own.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8fd9\u4e9b\u6307\u5357\u4e0d\u6db5\u76d6\u6dfb\u52a0\u5165\u836f\u54c1\u4e2d\u90a3\u4e9b\u4e0d\u80fd\u5355\u72ec\u5b58\u5728\u3001\u800c\u9700\u8981\u5728\u6d3b\u6027\u7269\u8d44\u4e2d\u6dfb\u52a0\u7a33\u5b9a\u5242\u4f7f\u6d3b\u6027\u7269\u8d28\u7a33\u5b9a\u7684\u6210\u5206\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;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">&nbsp;<\/strong><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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 0px 3px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;vertical-align: middle;border-bottom-width: 3px;border-bottom-style: solid;border-color: rgb(0, 110, 189);\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;border-bottom-width: 1px;border-bottom-style: solid;border-color: rgb(0, 110, 189);\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">4.&nbsp;DETERMINATION&nbsp;OF&nbsp;APPROPRIATE&nbsp;<\/strong><\/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;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">GMP&nbsp;<\/strong><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;line-height: 1.6;\">BASED&nbsp;ON&nbsp;TYPE&nbsp;AND&nbsp;USE OF&nbsp;<\/strong><\/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;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">EXCIPIENT &nbsp;<\/strong><\/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;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">&nbsp;\u57fa\u4e8e\u8f85\u6599\u7c7b\u578b\u548c\u7528\u9014\u7684\u9002\u5f53\u7684GMP\u51b3\u7b56<\/strong><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\">&nbsp;<\/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;\">4.1 In PIC\/S PE 009 Guide to Good Manufacturing Practice for Medicinal Products Annex 20, principles and examples of tools for quality risk management that can&nbsp; be applied to different aspects of pharmaceutical&nbsp; quality,&nbsp; including excipients, can be found.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u5728PIC \/ S PE 009 GMP\u6307\u5357\u9644\u5f5520\u4e2d\uff0c\u53ef\u4ee5\u627e\u5230\u80fd\u5e94\u7528\u4e8e\u836f\u54c1\u8d28\u91cf\uff0c\u5305\u62ec\u8f85\u6599\uff0c\u4e0d\u540c\u65b9\u9762\u7684\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u539f\u5219\u548c\u5de5\u5177\u5b9e\u4f8b\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;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\"><\/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;\">4.2&nbsp;These&nbsp;quality&nbsp;risk&nbsp;management&nbsp;principles&nbsp;should&nbsp;be&nbsp;used&nbsp;to&nbsp;assess&nbsp;the&nbsp;risks presented&nbsp;to&nbsp;the&nbsp;quality,&nbsp;safety&nbsp;and&nbsp;function&nbsp;of&nbsp;each&nbsp;excipient&nbsp;and&nbsp;to&nbsp;classify the&nbsp;excipient&nbsp;in&nbsp;question,&nbsp;e.g.&nbsp;as&nbsp;low&nbsp;risk,&nbsp;medium&nbsp;risk&nbsp;or&nbsp;high&nbsp;risk.&nbsp;Quality risk&nbsp;management&nbsp;tools&nbsp;such&nbsp;as&nbsp;those&nbsp;listed&nbsp;in&nbsp;Annex&nbsp;20&nbsp;(e.g.&nbsp;hazard&nbsp;analysisand&nbsp;critical controlpoints&nbsp;\u2014&nbsp;HACCP)&nbsp;should be&nbsp;used&nbsp;for&nbsp;this&nbsp;purpose.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8fd9\u4e9b\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u539f\u5219\u5e94\u7528\u4e8e\u8bc4\u4f30\u6bcf\u79cd\u8f85\u6599\u6240\u5448\u73b0\u7684\u8d28\u91cf\u3001\u5b89\u5168\u548c\u529f\u80fd\u65b9\u9762\u7684\u98ce\u9669\uff0c\u5e76\u5bf9\u6240\u8ff0\u8f85\u6599\u98ce\u9669\u7b49\u7ea7\u8fdb\u884c\u5206\u7c7b\uff0c\u5982\u4f4e\u98ce\u9669\u3001\u4e2d\u7b49\u98ce\u9669\u6216\u9ad8\u98ce\u9669\u3002&nbsp;\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u5de5\u5177\uff0c\u5982\u9644\u4ef620\u4e2d\u5217\u51fa\u7684\u300a\u98ce\u9669\u5206\u6790\u548c\u5173\u952e\u63a7\u5236\u70b9\u2014HACCP\u300b\u5e94\u7528\u4e8e\u6b64\u76ee\u7684\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;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/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;\">4.3 For each excipient from each manufacturer used, the manufacturing authorisation holder should identify the risks presented to the quality, safety and function of each excipient from its source \u2014 be that animal, mineral, vegetable, synthetic, etc. \u2014 through to its incorporation in the finished pharmaceutical dose form. Areas for consideration should include, but are not limited to:<\/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;\">&nbsp;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u6765\u81ea\u4e8e\u6bcf\u4e2a\u751f\u5382\u5546\u7684\u6bcf\u79cd\u8f85\u6599\uff0c\u751f\u4ea7\u8bb8\u53ef\u6301\u6709\u4eba\u5e94\u4ece\u5176\u6765\u6e90\u2014\u52a8\u7269\u3001\u77ff\u7269\u3001\u690d\u7269\u3001\u5408\u6210\u7269\u7b49\u2014\u8bc6\u522b\u6bcf\u79cd\u8f85\u6599\u7684\u8d28\u91cf\u3001\u5b89\u5168\u548c\u529f\u80fd\u98ce\u9669\uff0c\u76f4\u81f3\u5176\u6700\u7ec8\u5f62\u6210\u5236\u5242\u6210\u54c1\u3002&nbsp;\u8981\u8003\u8651\u7684\u5185\u5bb9\u5e94\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\uff1a<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/span><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;text-align: left;\">(a) transmissible spongiform encephalopathy;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">TSE\u98ce\u9669<\/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;\">&nbsp;<\/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;\">(b)&nbsp;potential&nbsp;for&nbsp;viral&nbsp;contamination;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u75c5\u6bd2\u6c61\u67d3\u7684\u53ef\u80fd\u6027<\/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;\">&nbsp;<\/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;\">(c)&nbsp;potential&nbsp;for&nbsp;microbiological&nbsp;or&nbsp;endotoxin\/pyrogen&nbsp;contamination;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u5fae\u751f\u7269\u6216\u5185\u6bd2\u7d20\/\u70ed\u6e90\u6c61\u67d3\u7684\u53ef\u80fd\u6027<\/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;\">&nbsp;<\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;line-height: 1.6;\">(d) potential, in general, for any impurity originating from the raw materials, e.g. aflatoxins or pesticides, or generated as part of the process and carried over, e.g. residual solvents and catalysts;<\/span><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;\"><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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u539f\u6599\u4e2d\u4ea7\u751f\u7684\u4efb\u4f55\u6742\u8d28\u5b58\u5728\u7684\u53ef\u80fd\u6027\uff0c\u4f8b\u5982\uff0c\u9ec4\u66f2\u9709\u7d20\u6216\u6740\u866b\u5242\uff0c\u6216\u5de5\u827a\u751f\u4ea7\u4e2d\u4ea7\u751f\u6216\u5e26\u5165\u7684\u6742\u8d28\uff0c\u4f8b\u5982\uff0c\u6b8b\u7559\u6eb6\u5242\u548c\u50ac\u5316\u5242\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;\">&nbsp;<\/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;\">(e)&nbsp;sterility assurance for excipients claimed to be sterile;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u65e0\u83cc\u4fdd\u8bc1\u7528\u4e8e\u8bc1\u660e\u8f85\u6599\u7684\u65e0\u83cc\u6027<\/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;\">&nbsp;<\/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;\">(f) potential for any impurities carried over from other processes, in absence of dedicated equipment and\/or&nbsp; facilities;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u975e\u4e13\u7528\u8bbe\u5907\/\u6216\u8bbe\u65bd\u4e2d\u5176\u4ed6\u5de5\u827a\u5e26\u5165\u6742\u8d28\u7684\u53ef\u80fd\u6027<\/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;\">&nbsp;<\/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;\">(g)&nbsp;environmental control and storage\/transportation conditions including&nbsp;cold&nbsp;chain&nbsp;management, if&nbsp;appropriate;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u73af\u5883\u63a7\u5236\u548c\u5b58\u8d2e\u8fd0\u8f93\u6761\u4ef6\uff0c\u9002\u5f53\u65f6\u5305\u62ec\u51b7\u94fe\u7ba1\u7406<\/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;\">&nbsp;<\/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;\">(h)&nbsp;supply&nbsp;chain&nbsp;complexity;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u4f9b\u5e94\u94fe\u590d\u6742\u7a0b\u5ea6<\/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;\">&nbsp;<\/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;\">(i)&nbsp;stability&nbsp;of&nbsp;excipient;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8f85\u6599\u7684\u7a33\u5b9a\u6027<\/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;\">&nbsp;<\/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;\">(j)&nbsp;packaging&nbsp;integrity&nbsp;evidence.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u5305\u88c5\u5b8c\u6574\u6027\u8bc1\u636e<\/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<\/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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\">4.4 Additionally, with respect to the use and function of each excipient, the manufacturing authorisation holder should consider:<span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;line-height: 1.6;\"><\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u6b64\u5916\uff0c\u5173\u4e8e\u6bcf\u79cd\u8f85\u6599\u7684\u4f7f\u7528\u548c\u529f\u80fd\u65b9\u9762\uff0c\u751f\u4ea7\u8bb8\u53ef\u6301\u6709\u4eba\u5e94\u8003\u8651\uff1a<\/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;\">&nbsp;<\/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;\">(a) the pharmaceutical form and use of the medicinal product containing the excipient;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u542b\u6709\u8f85\u6599\u7684\u836f\u54c1\u5242\u578b\u548c\u836f\u54c1\u7684\u7528\u9014<\/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;\">&nbsp;<\/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;\">(b)&nbsp;the&nbsp;function&nbsp;of&nbsp;the&nbsp;excipient&nbsp;in&nbsp;the&nbsp;formulation,&nbsp;e.g.&nbsp;lubricant&nbsp;in&nbsp;a tablet&nbsp;product&nbsp;or&nbsp;preservative&nbsp;material&nbsp;in &nbsp;a&nbsp;liquid&nbsp;formulation,&nbsp;etc.;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8f85\u6599\u5728\u5236\u5242\u4e2d\u7684\u529f\u80fd\uff0c\u4f8b\u5982\uff0c\u7247\u5242\u4e2d\u7684\u6da6\u6ed1\u5242\u3001\u6db2\u4f53\u5236\u5242\u4e2d\u7684\u9632\u8150\u5242\u7b49\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;\">&nbsp;<\/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;\">(c)&nbsp;the&nbsp;proportion&nbsp;of&nbsp;the&nbsp;excipient&nbsp;in &nbsp;the &nbsp;medicinal &nbsp;product composition;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8f85\u6599\u5728\u836f\u54c1\u6210\u5206\u4e2d\u6240\u5360\u7684\u6bd4\u4f8b<\/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;\">&nbsp;<\/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;\">(d)&nbsp;daily&nbsp;patient&nbsp;intake&nbsp;of the&nbsp;excipient;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u60a3\u8005\u7684\u65e5\u6444\u5165\u8f85\u6599\u91cf<\/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;\">&nbsp;<\/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;\">(e) any known quality defects\/fraudulent adulterations, both globally and at a local company level related to the&nbsp; excipient;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u5168\u7403\u8303\u56f4\u6216\u5f53\u5730\u516c\u53f8\u8303\u56f4\u4e0e\u8f85\u6599\u6709\u5173\u7684\u5df2\u77e5\u7684\u8d28\u91cf\u7f3a\u9677\u6216\u9020\u5047\u60c5\u51b5<\/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;\">&nbsp;<\/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;\">(f)&nbsp;whether&nbsp;the&nbsp;excipient&nbsp;is&nbsp;a composite;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8f85\u6599\u662f\u5426\u662f\u4e00\u79cd\u6210\u5206<\/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;\">&nbsp;<\/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;\">(g) known or potential impact on the critical quality attributes of the medicinal product;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u5bf9\u836f\u54c1\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u7684\u5df2\u77e5\u7684\u6216\u6f5c\u5728\u7684\u5f71\u54cd<\/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;\">&nbsp;<\/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;\">(h)&nbsp;other&nbsp;factors&nbsp;as&nbsp;identified&nbsp;or&nbsp;known&nbsp;to&nbsp;be&nbsp;relevant&nbsp;to&nbsp;assuring patient&nbsp;safety.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u5df2\u8bc6\u522b\u7684\u6216\u5df2\u77e5\u7684\u4e0e\u4fdd\u8bc1\u60a3\u8005\u5b89\u5168\u76f8\u5173\u7684\u5176\u4ed6\u56e0\u7d20<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">&nbsp;<\/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;\">4.5Having established and documented the risk profile of the excipient, the manufacturing authorisation holder should establish and document the elements of the PIC\/S PE 009 Guide to Good Manufacturing Practice for Medicinal Products that he\/she believes are needed to be in place in order to control and maintain the quality of the excipient, e.g. Annex 1 or\/and Annex 2; Guide to Good Manufacturing Practice for Medicinal Products Part II: Basic Requirements for Active Pharmaceutical Ingredients.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u5728\u5efa\u7acb\u6216\u8bb0\u5f55\u8f85\u6599\u7684\u98ce\u9669\u6982\u51b5\u4e4b\u540e\uff0c\u751f\u4ea7\u8bb8\u53ef\u6301\u6709\u4eba\u5e94\u5efa\u7acb\u548c\u8bb0\u5f55PIC\/S&nbsp;PE&nbsp;009 GMP\u7684\u8981\u7d20\uff0c\u8fd9\u4e9b\u8981\u7d20\u5e94\u662f\u8ba4\u4e3a\u5176\u4e3a\u63a7\u5236\u548c\u7ef4\u62a4\u8f85\u6599\u8d28\u91cf\u6240\u5fc5\u987b\u7684\uff0c\u4f8b\u5982\u9644\u5f551\u548c\/\u6216\u9644\u5f552\uff0cGMP\u7b2c\u4e8c\u90e8\u5206\u7528\u4f5c\u8d77\u59cb\u7269\u6599\u7684\u6d3b\u6027\u7269\u8d28\u7684\u57fa\u672c\u8981\u6c42\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;\">&nbsp;<\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\">4.6&nbsp;These&nbsp;elements&nbsp;will&nbsp;vary&nbsp;depending&nbsp;on&nbsp;the&nbsp;source,&nbsp;the&nbsp;supply&nbsp;chain&nbsp;and&nbsp;the subsequent&nbsp;use&nbsp;of&nbsp;the&nbsp;excipient,&nbsp;but&nbsp;as&nbsp;a&nbsp;minimum&nbsp;the&nbsp;following&nbsp;high&nbsp;level&nbsp;GMP elements&nbsp;should be&nbsp;considered by&nbsp;the&nbsp;manufacturing&nbsp;authorisation holder:<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8fd9\u4e9b\u8981\u7d20\u4f1a\u6839\u636e\u8f85\u6599\u7684\u6765\u6e90\u3001\u4f9b\u5e94\u94fe\u548c\u968f\u540e\u7684\u4f7f\u7528\u800c\u4e0d\u540c\uff0c\u4f46\u751f\u4ea7\u8bb8\u53ef\u6301\u6709\u4eba\u81f3\u5c11\u5e94\u8003\u8651\u4ee5\u4e0b\u6c34\u5e73\u7684GMP\u8981\u7d20\uff1a<\/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;\">&nbsp;<\/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;\">(a)&nbsp;establishment&nbsp;and&nbsp;implementation&nbsp;of&nbsp;an&nbsp;effective&nbsp;pharmaceutical quality&nbsp;system;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u5efa\u7acb\u548c\u5b9e\u65bd\u6709\u6548\u7684\u836f\u54c1\u8d28\u91cf\u4f53\u7cfb<\/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;\">&nbsp;<\/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;\">(b)&nbsp;sufficient&nbsp;competent&nbsp;and&nbsp;appropriately&nbsp;qualified&nbsp;personnel;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u5177\u5907\u8db3\u591f\u80dc\u4efb\u529b\u4e0e\u8d44\u8d28\u5408\u9002\u7684\u4eba\u5458<\/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;\">&nbsp;<\/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;\">(c) defined job descriptions for managerial and supervisory staff responsible for manufacturing and quality activities;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u786e\u5b9a\u5bf9\u751f\u4ea7\u548c\u8d28\u91cf\u6d3b\u52a8\u7ba1\u7406\u548c\u4e3b\u7ba1\u4eba\u5458\u7684\u5c97\u4f4d\u804c\u8d23<\/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;\">&nbsp;<\/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;\">(d) training programmes for all staff involved in manufacturing and quality activities (included but not limited to cleaning, engineering, laboratory, maintenance, materials management, safety, and technical services);<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u6240\u6d89\u53ca\u751f\u4ea7\u548c\u8d28\u91cf\u6d3b\u52a8\u7684\u5458\u5de5\u7684\u57f9\u8bad\u9879\u76ee\uff08\u5305\u62ec\u4f46\u4e0d\u4ec5\u9650\u4e8e\u6e05\u6d01\u3001\u5de5\u7a0b\u3001\u5b9e\u9a8c\u5ba4\u3001\u7ef4\u62a4\u3001\u6750\u6599\u7ba1\u7406\u3001\u5b89\u5168\u548c\u6280\u672f\u670d\u52a1\uff09<\/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;\">(e) training&nbsp; programmes&nbsp; related to health, hygiene and clothing&nbsp; as identified as necessary to the intended operations;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u4e0e\u5065\u5eb7\u3001\u536b\u751f\u548c\u670d\u88c5\u76f8\u5173\u7684\u57f9\u8bad\u9879\u76ee\uff0c\u5e76\u5bf9\u5176\u9884\u4f30\u64cd\u4f5c\u662f\u5fc5\u8981\u7684\uff1b&nbsp;<\/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;\">&nbsp;<\/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;\">(f)&nbsp;provision&nbsp;and&nbsp;maintenance&nbsp;of&nbsp;premises&nbsp;and&nbsp;equipment appropriate to&nbsp;the&nbsp;intended&nbsp;operations;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8bbe\u65bd\u548c\u8bbe\u5907\u7684\u7ed3\u6784\u548c\u7ef4\u62a4\u9002\u5408\u4e8e\u5176\u65e2\u5b9a\u64cd\u4f5c<\/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;\">&nbsp;<\/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;\">(g) documentation system(s) covering all processes and specifications for the various manufacturing and quality operations;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u6587\u4ef6\u8bb0\u5f55\u4f53\u7cfb\u8986\u76d6\u6240\u6709\u4e0d\u540c\u751f\u4ea7\u548c\u8d28\u91cf\u64cd\u4f5c\u7684\u52a0\u5de5\u548c\u8d28\u91cf\u6807\u51c6<\/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;\">&nbsp;<\/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;\">(h)&nbsp;systems&nbsp;for&nbsp;coding&nbsp;and&nbsp;identifying&nbsp;starting&nbsp;materials, intermediates and&nbsp;excipients&nbsp;to&nbsp;allow&nbsp;full&nbsp;traceability;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8d77\u59cb\u7269\u6599\u3001\u4e2d\u95f4\u4f53\u3001\u8f85\u6599\u7684\u7f16\u7801\u548c\u8bc6\u522b\u7cfb\u7edf\u53ef\u4ee5\u8fdb\u884c\u5168\u7a0b\u8ffd\u8e2a<\/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;\">&nbsp;<\/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;\">(i)&nbsp;qualification&nbsp;program&nbsp;of&nbsp;suppliers;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u4f9b\u5e94\u5546\u786e\u8ba4\u7a0b\u5e8f<\/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;\">&nbsp;<\/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;\">(j)&nbsp;system&nbsp;for&nbsp;quality&nbsp;control&nbsp;of&nbsp;the&nbsp;excipient and&nbsp;a&nbsp;responsible&nbsp;person independent&nbsp;from&nbsp;production&nbsp;to&nbsp;release&nbsp;the&nbsp;batches;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u5bf9\u8f85\u6599\u8fdb\u884c\u7cfb\u7edf\u7684\u8d28\u91cf\u63a7\u5236\uff0c\u6709\u4e00\u4e2a\u8d23\u4efb\u4eba\u72ec\u7acb\u4e8e\u751f\u4ea7\u4ee5\u5916\u6765\u653e\u884c\u6279\u6b21<\/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;\">&nbsp;<\/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;\">(k)&nbsp;retention&nbsp;of&nbsp;records&nbsp;for&nbsp;incoming&nbsp;materials &nbsp;and&nbsp;excipients &nbsp;and retention&nbsp;of&nbsp;samples&nbsp;of&nbsp;excipients&nbsp;for&nbsp;the periods&nbsp;required&nbsp;by&nbsp;PIC\/S Guide&nbsp;to&nbsp;Good&nbsp;Manufacturing&nbsp;Practice&nbsp;for&nbsp;Medicinal&nbsp;Products, Part&nbsp;II;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8fdb\u573a\u7269\u6599\u548c\u8f85\u6599\u8bb0\u5f55\u5e94\u4fdd\u5b58\uff0c\u8f85\u6599\u7559\u6837\u65f6\u95f4\u5e94\u7b26\u5408PIC\/S GMP\u7b2c\u4e8c\u90e8\u5206\u8981\u6c42<\/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;\">&nbsp;<\/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;\">(l)&nbsp;systems&nbsp;to&nbsp;ensure&nbsp;that&nbsp;any&nbsp;activity&nbsp;contracted&nbsp;out&nbsp;is&nbsp;subject&nbsp;to&nbsp;a written&nbsp;contract;<\/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;\">\u7cfb\u7edf\u4fdd\u8bc1\u6240\u6709\u5916\u5305\u6d3b\u52a8\u90fd\u6709\u4e66\u9762\u5408\u540c<\/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;\">&nbsp;<\/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;\">(m)&nbsp;maintenance &nbsp;of &nbsp;an &nbsp;effective &nbsp;system &nbsp;whereby &nbsp;complaints &nbsp;are reviewed&nbsp;and&nbsp;excipients&nbsp;may&nbsp;be&nbsp;recalled;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u6709\u6548\u7cfb\u7edf\u7684\u7ef4\u62a4\u3001\u5ba2\u6237\u6295\u8bc9\u8fdb\u884c\u5ba1\u6838\uff0c\u8f85\u6599\u53ef\u80fd\u88ab\u53ec\u56de<\/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;\">&nbsp;<\/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;\">(n)&nbsp;change management and deviation management system;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u53d8\u66f4\u7ba1\u7406\u548c\u504f\u5dee\u7ba1\u7406\u7cfb\u7edf<\/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;\">&nbsp;<\/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;\">(o)&nbsp;self-inspection&nbsp;program;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u81ea\u68c0\u7a0b\u5e8f<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/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;\">(p) environmental control and storage conditions.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u73af\u5883\u63a7\u5236\u548c\u5b58\u8d2e\u6761\u4ef6<\/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;\"><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;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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 0px 3px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;vertical-align: middle;border-bottom-width: 3px;border-bottom-style: solid;border-color: rgb(0, 110, 189);\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;border-bottom-width: 1px;border-bottom-style: solid;border-color: rgb(0, 110, 189);\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">5.&nbsp;DETERMINATION OF EXCIPIENT&nbsp;MANUFACTURER\u2019S RISK PROFILE &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/strong><\/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;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\u786e\u5b9a\u8f85\u6599\u751f\u4ea7\u7684\u98ce\u9669\u6982\u51b5<\/strong><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\"><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;\">5.1 After determination of the appropriate GMP, a gap analysis of the required GMP against the activities&nbsp; and capabilities of the excipient manufacturer should be performed.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u5728\u786e\u5b9a\u4e86\u9002\u5f53\u7684GMP\u540e\uff0c\u5e94\u9488\u5bf9\u8f85\u6599\u751f\u4ea7\u5546\u7684\u6d3b\u52a8\u548c\u80fd\u529b\u8fdb\u884c\u6240\u8981\u6c42\u7684GMP\u5dee\u8ddd\u5206\u6790<\/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;\">&nbsp;<\/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;\">5.2&nbsp;Data\/evidence&nbsp;to&nbsp;support&nbsp;the&nbsp;gap&nbsp;analysis&nbsp;should&nbsp;be&nbsp;obtained&nbsp;through&nbsp;audit or&nbsp;from&nbsp;information&nbsp;received&nbsp;from&nbsp;the excipient&nbsp;manufacturer.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u7528\u4ee5\u652f\u6301\u5dee\u8ddd\u5206\u6790\u7684\u6570\u636e\/\u8bc1\u636e\u5e94\u901a\u8fc7\u5ba1\u8ba1\u83b7\u5f97\uff0c\u6216\u4ece\u8f85\u6599\u751f\u4ea7\u5546\u5904\u83b7\u5f97\u7684\u4fe1\u606f\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;\">&nbsp;<\/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;\">5.3 Certification of quality systems and\/or GMP held by the excipient manufacturer and the standards against which these have been granted should be considered as such certification may fulfill the requirements, subject to national legislation requirements.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8d28\u91cf\u4f53\u7cfb\u7684\u8bc1\u4e66\/\u6216\u8f85\u6599\u751f\u4ea7\u5546\u6301\u6709\u7684GMP\u8bc1\u4e66\uff0c\u548c\u9881\u5e03\u8bc1\u4e66\u6240\u4f9d\u636e\u7684\u6807\u51c6\u5e94\u8fdb\u884c\u8003\u8651\uff0c\u56e0\u4e3a\u8be5\u8ba4\u8bc1\u53ef\u80fd\u4f1a\u6ee1\u8db3\u8fd9\u4e9b\u8981\u6c42\uff0c\u8fd9\u4e9b\u8981\u6c42\u53d7\u56fd\u5bb6\u7acb\u6cd5\u8981\u6c42\u7684\u9650\u5236\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;\">&nbsp;<\/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;\">5.4 Any gaps identified between the required GMP and the activities and capabilities of the excipient manufacturer should be documented.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u6240\u8bc6\u522b\u51fa\u7684GMP\u8981\u6c42\u4e0e\u8f85\u6599\u751f\u4ea7\u5546\u7684\u6d3b\u52a8\u53ca\u80fd\u529b\u4e4b\u95f4\u7684\u5dee\u8ddd\u5e94\u8fdb\u884c\u8bb0\u5f55\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;\">Furthermore, the manufacturing authorisation holder should perform a further risk assessment to determine the risk profile, e.g. low risk, medium risk or high risk, for that excipient manufacturer. PIC\/S PE 009 Guide to Good Manufacturing Practice for Medicinal Products Annex 20: Quality Risk Management should be used for that purpose. Quality risk management tools such as those listed there \u2014 HACCP etc. \u2014should be used for this.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u53e6\u5916\uff0c\u751f\u4ea7\u8bb8\u53ef\u6301\u6709\u4eba\u5e94\u5b9e\u65bd\u8fdb\u4e00\u6b65\u98ce\u9669\u8bc4\u4f30\uff0c\u4ee5\u51b3\u5b9a\u8be5\u8f85\u6599\u751f\u4ea7\u5546\u7684\u98ce\u9669\u6982\u51b5\uff0c\u4f8b\u5982\uff0c\u4f4e\u98ce\u9669\u3001\u4e2d\u7b49\u98ce\u9669\u6216\u9ad8\u98ce\u9669\u3002PIC\/S&nbsp;PE&nbsp;009 &nbsp;GMP\u6307\u5357\u9644\u4ef620\uff1a\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u5de5\u5177\uff0c\u4f8b\u5982\u5217\u4e8e\u5176\u4e2d\u7684\u90a3\u4e9b&#8212;HACCP\u2014\u7b49\u4e00\u4e00\u5e94\u7528\u4e8e\u6b64\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;\">&nbsp;<\/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;\">5.5 The manufacturing authorisation holder should have a series of strategies ranging from acceptance through control to unacceptable for the different risk profiles and based on these a control strategy, e.g. audit, document retrieval and testing, should be established.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u751f\u4ea7\u8bb8\u53ef\u6301\u6709\u4eba\u5e94\u5236\u5b9a\u4e00\u7cfb\u5217\u7684\u7b56\u7565\uff0c\u5bf9\u4e8e\u4e0d\u540c\u7684\u98ce\u9669\u6982\u51b5\u4ece\u53ef\u63a5\u53d7\u5230\u4e0d\u53ef\u63a5\u53d7\uff0c\u57fa\u4e8e\u8fd9\u4e9b\uff0c\u5e94\u5efa\u7acb\u4e00\u79cd\u63a7\u5236\u7b56\u7565\uff0c\u4f8b\u5982\uff0c\u5ba1\u8ba1\u3001\u6587\u4ef6\u6062\u590d\u548c\u68c0\u6d4b\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;\">&nbsp;<\/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;text-align: center;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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 0px 3px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;vertical-align: middle;border-bottom-width: 3px;border-bottom-style: solid;border-color: rgb(0, 110, 189);\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;border-bottom-width: 1px;border-bottom-style: solid;border-color: rgb(0, 110, 189);\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">6.&nbsp;CONFIRMATION OF APPLICATION OF&nbsp;APPROPRIATE GMP &nbsp;&nbsp;<\/strong><\/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;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\u9002\u5f53\u7684GMP\u7533\u8bf7\u786e\u8ba4<\/strong><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;font-style: normal;font-variant: normal;font-weight: normal;letter-spacing: 1px;line-height: 22.3999996185303px;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;\">6.1 Once the appropriate GMP for the&nbsp; excipient&nbsp; and the risk profile of the excipient manufacturer have been defined, ongoing risk review should be performed through mechanisms such as:<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u4e00\u65e6\u5b9a\u4e49\u4e86\u8f85\u6599\u9002\u7528\u7684GMP\uff0c\u4ee5\u53ca\u8f85\u6599\u751f\u4ea7\u5546\u7684\u98ce\u9669\u6982\u51b5\uff0c\u540e\u7eed\u901a\u8fc7\u4e00\u5b9a\u673a\u5236\u8fdb\u884c\u6301\u7eed\u98ce\u9669\u8bc4\u4f30\uff0c\u5982\uff1a<\/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;\">&nbsp;<\/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;\">(a) numberof defects connected to batches of excipient received;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u4e0e\u6536\u5230\u7684\u8f85\u6599\u6279\u6b21\u76f8\u5173\u7684\u7f3a\u9677\u6570\u91cf<\/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;\">&nbsp;<\/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;\">(b)&nbsp;type\/severity&nbsp;of&nbsp;such&nbsp;defects;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8fd9\u4e9b\u7f3a\u9677\u7684\u7c7b\u578b\u548c\u4e25\u91cd\u7a0b\u5ea6<\/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;\">&nbsp;<\/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;\">(c) monitoring and trend analysis of excipient quality;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u8f85\u6599\u8d28\u91cf\u7684\u76d1\u63a7\u548c\u8d8b\u52bf\u5206\u6790<\/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;\">&nbsp;<\/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;\">(d) loss of relevant quality system and\/or GMP certification by excipient manufacturer;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u76f8\u5173\u8d28\u91cf\u4f53\u7cfb\u7684\u7f3a\u5931\u548c\/\u6216\u8f85\u6599\u751f\u4ea7\u5546\u6301\u6709\u7684GMP\u8bc1\u4e66<\/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;\">&nbsp;<\/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;\">(d) observation of trends in drug product quality attributes\uff1bthis will depend on the nature and role of excipient;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u836f\u54c1\u8d28\u91cf\u5c5e\u6027\u7684\u8d8b\u52bf\u89c2\u5bdf\uff0c\u8fd9\u4e9b\u5c06\u53d6\u51b3\u4e8e\u8f85\u6599\u7684\u5c5e\u6027\u548c\u4f5c\u7528<\/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;\">(e)&nbsp;observed&nbsp;organisational,&nbsp;procedural&nbsp;or&nbsp;technical\/process&nbsp;changes at the&nbsp;excipient&nbsp;manufacturer;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u89c2\u5bdf\u5230\u7684\u8f85\u6599\u751f\u4ea7\u5546\u7684\u6709\u7ec4\u7ec7\u6027\u7684\u3001\u7a0b\u5e8f\u6027\u7684\u6216\u6280\u672f\u6027\u7684\/\u5de5\u827a\u53d8\u66f4<\/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;\">&nbsp;<\/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;\">(f) audit\/re-audit of excipient manufacturer;<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u5bf9\u8f85\u6599\u751f\u4ea7\u5546\u8fdb\u884c\u5ba1\u8ba1\/\u590d\u5ba1<\/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;\">(g)&nbsp;questionnaires.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u95ee\u5377<\/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;\">Based&nbsp;on&nbsp;the&nbsp;outcome&nbsp;of&nbsp;the&nbsp;risk&nbsp;review,&nbsp;the&nbsp;established&nbsp;control&nbsp;strategy&nbsp;should be reviewed&nbsp;and&nbsp;revised&nbsp;if&nbsp;needed.<\/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;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(0, 110, 189);\">\u57fa\u4e8e\u98ce\u9669\u5ba1\u6838\u7684\u7ed3\u679c\uff0c\u5fc5\u8981\u65f6\u5e94\u5bf9\u5df2\u5efa\u7acb\u7684\u63a7\u5236\u7b56\u7565\u8fdb\u884c\u5ba1\u6838\u4e0e\u4fee\u8ba2\u3002<\/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\">\u6b27\u76dfGMP\/GDP\u6cd5\u89c4\u6c47\u7f16\uff08\u4e2d\u82f1\u6587\u5bf9\u7167\u7248\uff09<\/h2>\n<p class=\"cps_inner_info_desc\">\u4f5c\u8005\uff1a???<\/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\">\u4e16\u754c\u5404\u56fdGMP\u95ee\u7b54\u96c6\u8403<\/h2>\n<p class=\"cps_inner_info_desc\">\u4f5c\u8005\uff1a\u4e01\u601d\u5cf0\u3000\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<\/section>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\">&nbsp;<br  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<p><br  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\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>\u667a\u80fd\u65f6\u4ee3\uff1a\u5927\u6570\u636e\u4e0e\u667a\u80fd\u9769\u547d\u91cd\u65b0\u5b9a\u4e49\u672a\u6765 \u4f5c\u8005\uff1a\u5434\u519b \u5f53\u5f53 \u5e7f\u544a \u8d2d\u4e70 \u5916\u8d44\u5927\u578b\u5236\u836f\u516c\u53f8\u6280\u672f\u3001\u7814\u53d1\u3001\u8d28\u91cf\u603b\u76d1\uff0c\u9a8c [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":12615,"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\/12614"}],"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=12614"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/12614\/revisions"}],"predecessor-version":[{"id":12618,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/12614\/revisions\/12618"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/12615"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=12614"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=12614"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=12614"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}