{"id":57844,"date":"2018-11-15T01:00:00","date_gmt":"2018-12-07T02:27:46","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/80dd18dc36\/"},"modified":"2018-12-07T10:27:47","modified_gmt":"2018-12-07T02:27:47","slug":"80dd18dc36","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/57844\/","title":{"rendered":"\u5e72\u8d27 | \u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u9879\u76ee\u7ba1\u7406\u53ca\u5e38\u89c1\u95ee\u9898\u63a2\u8ba8"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section class=\"\" style=\"margin: 10px 0px 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;font-style: normal;font-variant: normal;font-weight: 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1em;font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u6458 \u8981<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><\/strong><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u672c\u6587\u65e8\u5728\u4ee5\u9879\u76ee\u7ba1\u7406\u7684\u89d2\u5ea6\uff0c\u4ece\u6218\u7565\u4e00\u81f4\u6027\u3001\u9879\u76ee\u542f\u52a8\u3001\u8303\u56f4\u7ba1\u7406\u3001\u8fdb\u5ea6\u7ba1\u7406\u3001\u6210\u672c\u7ba1\u7406\u3001\u8d28\u91cf\u7ba1\u7406\u3001\u4eba\u5458\u4e0e\u6c9f\u901a\u7ba1\u7406\u3001\u98ce\u9669\u7ba1\u7406\u3001\u4f9b\u5e94\u5546\u4e0e\u5408\u540c\u7ba1\u7406\u548c\u9879\u76ee\u6536\u5c3e\u7b49\u65b9\u9762\u63a2\u8ba8\u76ee\u524d\u56fd\u5185\u70ed\u95e8\u7684\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u7ba1\u7406\uff0c\u540c\u65f6\u7ed3\u5408\u5b9e\u9645\u5bf9\u5e38\u89c1\u95ee\u9898\u8fdb\u884c\u8ba8\u8bba\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u81ea 2003 \u7248 GCP \u9881\u5e03\u4ee5\u6765\uff0c\u6211\u56fd\u4e34\u5e8a\u8bd5\u9a8c\u53d6\u5f97\u4e86\u5feb \u901f\u53d1\u5c55\uff0c\u4f46\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u4f5c\u4e3a\u6574\u4e2a\u4e34\u5e8a\u7814\u7a76\u9886\u57df\u7684\u4e00 \u4e2a\u5206\u652f\uff0c\u4e00\u76f4\u672a\u53d7\u91cd\u70b9\u5173\u6ce8\u3002\u76f4\u81f3 2015 \u5e74 7 \u6708 22 \u65e5\u539f \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u53d1\u5e03\u4e86\u7b2c 117 \u53f7\u516c\u544a(\u4ee5\u4e0b\u7b80 \u79f0\u201c7.22 \u4e8b\u4ef6\u201d)\uff0c\u5f15\u53d1\u4e86\u65b0\u4e00\u8f6e\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6539\u9769\uff0c\u52a0\u4e0a \u201c\u201d\u7684\u52a9\u63a8\uff0c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u88ab\u63a8\u5230\u4e86\u98ce \u53e3\u6d6a\u5c16\u3002\u5927\u91cf\u9700\u6c42\u7a81\u7136\u6d8c\u73b0\uff0c\u4f46\u7814\u7a76\u4e2d\u5fc3\u548c\u4e13\u4e1a\u4eba\u624d\u7684 \u7d27\u7f3a\u5f15\u53d1\u4e86\u5f88\u591a\u95ee\u9898\u3002\u672c\u6587\u4e3b\u8981\u4ece\u9879\u76ee\u7ba1\u7406\u89d2\u5ea6\u63a2\u8ba8\u751f \u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u7684\u7ba1\u7406\u548c\u95ee\u9898\u3002 <br  \/><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\"><br  \/><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"color: rgb(255, 0, 0);\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">1 \u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u548c\u73b0\u4ee3\u9879\u76ee\u7ba1\u7406\u7684\u6982\u5ff5<\/span><\/strong><\/span><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">&nbsp;<\/span><\/strong><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><strong><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">1.1 \u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c&nbsp;<\/span><\/strong><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c(bioequivalence trial\uff0cBE \u8bd5\u9a8c)\u662f\u6307\u91c7\u7528\u751f\u7269\u5229\u7528\u5ea6\u7814\u7a76\u65b9\u6cd5\uff0c\u4ee5\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u4e3a\u6307\u6807\uff0c \u6bd4\u8f83\u540c\u4e00\u79cd\u836f\u7269\u7684\u76f8\u540c\u6216\u4e0d\u540c\u5242\u578b\u7684\u5236\u5242\uff0c\u5728\u76f8\u540c\u7684\u8bd5 \u9a8c\u6761\u4ef6\u4e0b\uff0c\u5176\u6d3b\u6027\u6210\u5206\u5438\u6536\u7a0b\u5ea6\u548c\u901f\u5ea6\u6709\u65e0\u7edf\u8ba1\u5b66\u5dee\u5f02 \u7684\u4eba\u4f53\u8bd5\u9a8c\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">BE \u8bd5\u9a8c\u4e0e\u5e38\u89c4\u7684\u2161\u3001\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6709\u8f83\u5927\u7684\u533a\u522b\uff0c \u5b58\u5728\u4e00\u4e9b\u7279\u70b9\u3002\u5982\u4e3a\u5355\u4e2d\u5fc3\u7814\u7a76\uff0c\u5065\u5eb7\u53d7\u8bd5\u8005\u3001\u4f8b\u6570\u5c11\u3001 \u5468\u671f\u77ed\u3001\u5de5\u4f5c\u91cf\u96c6\u4e2d\u3001\u9700\u8981\u4e13\u4e1a\u751f\u7269\u6837\u672c\u7ba1\u7406\u4e0e\u68c0\u6d4b\u7b49\u3002 \u8fd9\u540c\u65f6\u7ed9 BE \u8bd5\u9a8c\u5e26\u6765\u4e86\u4e0e\u2161\u3001\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e0d\u540c\u7684\u95ee\u9898\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><strong><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">1.2 \u73b0\u4ee3\u9879\u76ee\u7ba1\u7406<\/span><\/strong><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u9879\u76ee\u7ba1\u7406\u662f\u6307\u5728\u9879\u76ee\u6d3b\u52a8\u4e2d\u8fd0\u7528\u4e13\u95e8\u7684\u77e5\u8bc6\u3001\u6280\u80fd\u3001\u5de5\u5177\u548c\u65b9\u6cd5\uff0c\u4f7f\u9879\u76ee\u80fd\u591f\u5728\u6709\u9650\u8d44\u6e90\u7684\u6761\u4ef6\u4e0b\uff0c\u5b9e\u73b0\u6216 \u8d85\u8fc7\u8bbe\u5b9a\u7684\u9700\u6c42\u548c\u671f\u671b\u7684\u8fc7\u7a0b\u3002\u9879\u76ee\u7ba1\u7406\u662f\u5bf9\u4e00\u4e9b\u6210\u529f \u5730\u8fbe\u6210\u4e00\u7cfb\u5217\u76ee\u6807\u76f8\u5173\u7684\u6d3b\u52a8(\u5982\u4efb\u52a1)\u7684\u6574\u4f53\u76d1\u6d4b\u548c\u7ba1\u63a7\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u73b0\u4ee3\u9879\u76ee\u7ba1\u7406\u7531\u5f7c\u5f97\u00b7\u5fb7\u9c81\u514b 1954 \u5e74\u5728\u300a\u7ba1\u7406\u7684 \u5b9e\u8df5\u300b\u4e2d\u63d0\u51fa\uff0c\u662f\u76ee\u524d\u56fd\u9645\u516c\u8ba4\u7684\u79d1\u5b66\u7684\u9879\u76ee\u7ba1\u7406\u7406\u5ff5\u3002 \u5176\u5c06\u9879\u76ee\u7ba1\u7406\u8fc7\u7a0b\u5206\u6210\u201c\u542f\u52a8\uff0c\u89c4\u5212\uff0c\u6267\u884c\uff0c\u76d1\u63a7\uff0c\u6536 \u5c3e\u201d\u8fd9 5 \u5927\u8fc7\u7a0b\u7ec4\uff0c\u540c\u65f6\u63d0\u51fa 13 \u9879\u5f71\u54cd\u56e0\u7d20\uff0c\u4e3b\u8981\u5305\u542b \u201c\u8303\u56f4\uff0c\u8fdb\u5ea6\uff0c\u6210\u672c\uff0c\u8d28\u91cf\uff0c\u98ce\u9669\uff0c\u8d44\u6e90\u201d\u7b49\u5404\u56e0\u7d20\u76f8\u4e92\u5f71\u54cd\uff0c\u6784\u6210\u4e86\u9879\u76ee\u7ba1\u7406\u7684\u7cfb\u7edf\u3002 BE \u8bd5\u9a8c\u4f5c\u4e3a\u9879\u76ee\uff0c\u4e5f\u53ef\u4ee5\u8fd0\u7528\u73b0\u4ee3\u9879\u76ee\u7ba1\u7406\u7406\u5ff5\uff0c \u4f18\u5316 BE \u8bd5\u9a8c\u7684\u7ba1\u7406\u3002 <br  \/><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\"><\/span><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"color: rgb(255, 0, 0);\"><strong><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">2 \u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u4e2d\u7684\u9879\u76ee\u7ba1\u7406&nbsp;<\/span><\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><strong><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">2.1 \u7ec4\u7ec7\u6218\u7565\u7684\u4e00\u81f4\u6027&nbsp;<\/span><\/strong><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u6240\u6709\u7684\u9879\u76ee\u90fd\u79bb\u4e0d\u5f00\u7ec4\u7ec7\uff0c\u7ec4\u7ec7\u7ed9\u9879\u76ee\u63d0\u4f9b\u4e86\u8d44\u6e90\uff0c\u9879\u76ee\u7684\u6700\u7ec8\u76ee\u7684\u662f\u4e3a\u7ec4\u7ec7\u521b\u9020\u5229\u6da6\u3002BE \u8bd5\u9a8c\u4e5f\u5982\u6b64\uff0c\u5728\u7acb\u9879\u65f6\u5fc5\u987b\u4e0e\u516c\u53f8\u9ad8\u5c42\u7684\u6218\u7565\u601d\u8def\u4fdd\u6301\u4e00\u81f4\uff0c\u5982\u6cbb\u7597\u9886 \u57df\u3001\u54c1\u79cd\u7684\u9009\u62e9\u3001\u662f\u5426\u7b26\u5408\u516c\u53f8\u5b9e\u9645\u60c5\u51b5\u3001\u662f\u5426\u80fd\u591f\u5e26 \u6765\u8f83\u5927\u5229\u6da6 \/ \u6210\u672c\u6bd4\u7b49\u3002\u53ea\u6709\u4e0e\u7ec4\u7ec7\u4fdd\u6301\u6218\u7565\u4e00\u81f4\u6027\uff0c \u9879\u76ee\u5728\u540e\u7eed\u7684\u8fd0\u4f5c\u4e2d\u624d\u4f1a\u5f97\u5230\u4f18\u5148\u7684\u8d44\u6e90\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u82e5\u5728\u9879\u76ee\u8fd0\u4f5c\u4e2d\u4e0e\u7ec4\u7ec7\u6218\u7565\u4e00\u81f4\u6027\u53d1\u751f\u504f\u79bb\uff0c\u5fc5\u987b \u53ca\u65f6\u7ea0\u6b63\uff0c\u751a\u81f3\u679c\u65ad\u7ec8\u6b62\u9879\u76ee\uff0c\u51cf\u5c11\u8d44\u6e90\u6d6a\u8d39\u3002\u56e0\u6b64\uff0c \u5728 BE \u8bd5\u9a8c\u6574\u4e2a\u8fc7\u7a0b\u4e2d\u8981\u968f\u65f6\u4e0e\u7ba1\u7406\u5c42\u6216\u8d44\u6e90\u63d0\u4f9b\u65b9\u4fdd \u6301\u8054\u7cfb\uff0c\u4ee5\u786e\u4fdd BE \u8bd5\u9a8c\u7684\u7ed3\u679c\u80fd\u8fbe\u5230\u9884\u671f\u7684\u7ed3\u679c\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><strong><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">2.2 \u9879\u76ee\u542f\u52a8&nbsp;<\/span><\/strong><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u9879\u76ee\u5728\u5b8c\u6210\u7acb\u9879\uff0c\u5e76\u5f97\u5230\u7ba1\u7406\u5c42\u6279\u51c6\u540e\uff0c\u9700\u8981\u5236\u5b9a \u521d\u6b65\u9879\u76ee\u7ba1\u7406\u8ba1\u5212\u3002\u6b64\u8ba1\u5212\u5c5e\u4e8e\u7efc\u5408\u7684\u3001\u5e7f\u6cdb\u7684\u8ba1\u5212\uff0c \u5e94\u5305\u542b\u591a\u65b9\u9762\u5185\u5bb9\uff0c\u4e0d\u5fc5\u8be6\u5c3d\u3002\u9879\u76ee\u7ba1\u7406\u8ba1\u5212\u5f97\u5230\u7ba1\u7406 \u5c42\u6279\u51c6\u540e\uff0c\u5373\u53ef\u53ec\u5f00\u9879\u76ee\u542f\u52a8\u4f1a(kick off meeting)\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u9879\u76ee\u542f\u52a8\u4f1a\u5c5e\u4e8e\u4e00\u79cd\u5e7f\u6cdb\u7684\u3001\u52a1\u865a\u7684\u4f1a\u8bae\uff0c\u5176\u4e3b\u8981 \u76ee\u7684\u662f\u660e\u786e\u5404\u65b9\u804c\u8d23\uff0c\u52a8\u5458\u5404\u65b9\u79ef\u6781\u6027\uff0c\u786e\u5b9a\u91cc\u7a0b\u7891\u3002 \u542f\u52a8\u4f1a\u5e94\u5c3d\u91cf\u5168\u9762\u5730\u9080\u8bf7\u9879\u76ee\u76f8\u5173\u4eba\u5458\u53c2\u52a0\uff0c\u6700\u597d\u5f53\u573a \u660e\u786e\u804c\u8d23\uff0c\u6e05\u9664\u540e\u7eed\u5de5\u4f5c\u7684\u6f5c\u5728\u969c\u788d\u3002\u806a\u660e\u7684\u9879\u76ee\u7ba1\u7406\u8005\uff0c \u5f80\u5f80\u4f1a\u9080\u8bf7\u9879\u76ee\u8d44\u52a9\u65b9\u6216\u516c\u53f8\u9ad8\u5c42\u53c2\u4f1a\uff0c\u8fd9\u6837\u53ef\u4ee5\u63d0\u9ad8 \u4f1a\u8bae\u7684\u6548\u7387\u548c\u6743\u5a01\u6027\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">BE \u8bd5\u9a8c\u4e0e\u5176\u4ed6\u4e34\u5e8a\u8bd5\u9a8c\u4e00\u6837\uff0c\u5b58\u5728\u4e00\u79cd\u66f4\u7ec6\u5316\u7684\u201c\u4e2d \u5fc3\u542f\u52a8\u4f1a\u201d\uff0c\u5373\u5728\u7814\u7a76\u4e2d\u5fc3\u53ec\u5f00\u7684\u9879\u76ee\u542f\u52a8\u4f1a\uff0c\u4ec5\u9488\u5bf9\u4e00 \u4e2a\u7814\u7a76\u4e2d\u5fc3\uff0c\u662f\u8be5\u4e2d\u5fc3\u8bd5\u9a8c\u542f\u52a8\u7684\u91cc\u7a0b\u7891\u3002\u4e2d\u5fc3\u542f\u52a8\u4f1a \u7684\u4f5c\u7528\u7c7b\u4f3c\u9879\u76ee\u542f\u52a8\u4f1a\uff0c\u540c\u65f6\u8fd8\u9700\u5bf9\u7814\u7a76\u8005\u8fdb\u884c\u57f9\u8bad\u3002 \u56e0\u6b64\uff0c\u4e2d\u5fc3\u542f\u52a8\u4f1a\u9700\u8981\u6240\u6709\u53c2\u4e0e\u8bd5\u9a8c\u7684\u7814\u7a76\u8005\u53c2\u52a0\uff0c\u8fd9 \u6837\u624d\u80fd\u8fbe\u5230\u8f83\u7406\u60f3\u7684\u6548\u679c\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><strong><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">2.3 \u8303\u56f4\u7ba1\u7406&nbsp;<\/span><\/strong><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u9879\u76ee\u7ba1\u7406\u5305\u542b\u5f88\u591a\u56e0\u7d20\uff0c\u5176\u4e2d\u8303\u56f4\u3001\u8fdb\u5ea6\u3001\u6210\u672c\u5c5e \u4e8e\u57fa\u7840\u201c\u94c1\u4e09\u89d2\u201d\u3002\u8303\u56f4\u6307\u9879\u76ee\u6240\u89c4\u5b9a\u7684\u9700\u8981\u5b8c\u6210\u7684\u5de5\u4f5c\uff0c \u5373\u7ed9\u9879\u76ee\u5212\u5b9a\u8fb9\u754c\u7ebf\uff0c\u54ea\u4e9b\u5de5\u4f5c\u80fd\u505a\uff0c\u54ea\u4e9b\u5de5\u4f5c\u4e0d\u80fd\u505a\u3002 \u8303\u56f4\u5c0f\u4e86\uff0c\u6210\u672c\u5c31\u80fd\u964d\u4f4e\uff0c\u8fdb\u5ea6\u5c31\u80fd\u52a0\u5feb;\u53cd\u4e4b\uff0c\u6210\u672c\u5347\u9ad8\uff0c \u8fdb\u5ea6\u5ef6\u671f\u3002 BE\u8bd5\u9a8c\u7684\u8303\u56f4\u6307\u5b8c\u6210BE\u8bd5\u9a8c\u8fc7\u7a0b\u5e76\u83b7\u5f97\u8bd5\u9a8c\u7ed3\u679c\uff0c BE \u8bd5\u9a8c\u7684\u8d77\u70b9\u8fb9\u754c\u4e3a\u201c\u836f\u5b66\u7814\u7a76\u5df2\u7ed3\u675f\u5e76\u83b7\u5f97\u836f\u54c1\u68c0\u9a8c \u62a5\u544a\u4e66(certificate of analysis\uff0cCOA)\u53ca\u8bd5\u9a8c\u836f\u7269\u201d\uff0c\u7ec8 \u70b9\u8fb9\u754c\u4e3a\u201c\u83b7\u5f97\u4e34\u5e8a\u603b\u7ed3\u62a5\u544a\u5e76\u4ea4\u7ed9\u6ce8\u518c\u90e8\u95e8\u201d\u3002\u8fb9\u754c \u4e4b\u5916\u7684\u5de5\u4f5c\uff0c\u4e0d\u5c5e\u4e8e\u6b64\u9879\u76ee\u7684\u8303\u56f4\uff0c\u5982\u4e0a\u6e38\u7684\u836f\u5b66\u7814\u7a76\uff0c \u4e0b\u6e38\u7684\u6ce8\u518c\u5de5\u4f5c\u3002\u56e0\u6b64\u5e94\u5c3d\u91cf\u7f29\u5c0f\u8303\u56f4\uff0c\u4ece\u800c\u964d\u4f4e\u6210\u672c\uff0c \u7f29\u77ed\u8fdb\u5ea6\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><strong><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">2.4 \u8fdb\u5ea6\u7ba1\u7406&nbsp;<\/span><\/strong><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u8fdb\u5ea6\u7ba1\u7406\u662f\u9879\u76ee\u7ba1\u7406\u4e2d\u7684\u91cd\u8981\u56e0\u7d20\uff0c\u4e5f\u662f\u7ec4\u7ec7\u7ba1\u7406 \u5c42\u6700\u5173\u5fc3\u7684\u56e0\u7d20\u3002\u5728\u9879\u76ee\u65e9\u671f\u9700\u8981\u5236\u5b9a\u521d\u6b65\u7684\u8fdb\u5ea6\u8ba1\u5212\uff0c \u4e00\u822c\u5305\u542b\u5728\u7acb\u9879\u8fc7\u7a0b\u4e2d\uff0c\u540e\u7eed\u9700\u8981\u5355\u72ec\u5236\u5b9a\u8be6\u7ec6\u7684\u8fdb\u5ea6 \u8ba1\u5212\u3002\u8fdb\u5ea6\u8ba1\u5212\u7684\u5236\u5b9a\u4e00\u822c\u91c7\u7528\u201c\u5173\u952e\u8def\u5f84\u6cd5\u201d\u5bfb\u627e\u6700 \u77ed\u8fdb\u5ea6\u8def\u7ebf\uff0c\u5373\u5173\u952e\u8282\u70b9\u94fe\u63a5\u800c\u6210\u7684\u9879\u76ee\u6d41\u7a0b\u3002\u5728\u5236\u5b9a \u8fdb\u5ea6\u8ba1\u5212\u65f6\uff0c\u9700\u8981\u8bbe\u7f6e\u8fdb\u5ea6\u7f13\u51b2\uff0c\u4e00\u822c\u9884\u7559 20% \u7684\u65f6\u95f4 \u4f5c\u4e3a\u7a81\u53d1\u4e8b\u4ef6\u7684\u5904\u7406\u5468\u671f\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">BE \u8bd5\u9a8c\u7684\u5173\u952e\u8def\u5f84\u4e3a \uff1a\u8bd5\u9a8c\u836f\u7269 COA \u51c6\u5907\u2192\u65b9\u6848 \u8bbe\u8ba1\u53ca\u4e2d\u5fc3\u9009\u62e9 \u2192 \u4f26\u7406\u6279\u4ef6 \u2192 \u542f\u52a8\u4f1a \u2192 \u9996\u4f8b\u5165\u7ec4 \u2192 \u672b\u4f8b\u7ed3\u675f \u2192 \u603b\u7ed3\u62a5\u544a\u3002\u5176\u4e2d\u4e3b\u8981\u9650\u901f\u8282\u70b9\u4e3a\u201c\u8bd5\u9a8c\u836f\u7269 \u51c6\u5907\u201d\u548c\u201c\u4f26\u7406\u6279\u4ef6\u201d\uff0c\u56e0\u6b64\u5728\u5236\u5b9a\u8fdb\u5ea6\u8ba1\u5212\u65f6\uff0c\u5e94\u5c3d\u91cf \u7ed9\u8fd9\u4e24\u4e2a\u9650\u901f\u8282\u70b9\u9884\u7559\u8f83\u591a\u7f13\u51b2\u65f6\u95f4\uff0c\u5e76\u63d0\u524d\u5236\u5b9a\u98ce\u9669 \u9884\u9632\u63aa\u65bd\u3002 \u7ba1\u7406\u5c42\u6700\u5e0c\u671b\u8fdb\u5ea6\u52a0\u5feb\u3002\u52a0\u5feb\u8fdb\u5ea6\u5e38\u7528\u7684\u4e24\u79cd\u65b9\u6cd5 \u662f\u201c\u8fdb\u5ea6\u538b\u7f29\u201d\u548c\u201c\u8d76\u5de5\u201d\u3002\u8fdb\u5ea6\u538b\u7f29\u5373\u5e76\u884c\u5b89\u6392\u591a\u9879\u5de5 \u4f5c\u540c\u65f6\u8fdb\u884c\uff0c\u4ee5\u7f29\u77ed\u5468\u671f\uff0c\u4f46\u5c06\u589e\u52a0\u9879\u76ee\u98ce\u9669\uff0c\u4ee5\u98ce\u9669 \u6362\u8fdb\u5ea6 ;\u8d76\u5de5\u5373\u52a0\u73ed\uff0c\u4f46\u4f1a\u589e\u52a0\u6210\u672c\u548c\u964d\u4f4e\u5458\u5de5\u6ee1\u610f\u5ea6\uff0c \u4ee5\u6210\u672c\u6362\u8fdb\u5ea6\u3002 \u7531\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u8fc7\u7a0b\u4e25\u8c28\uff0c\u5f88\u96be\u8fdb\u5ea6\u538b\u7f29\u3002\u800c BE \u8bd5 \u9a8c\u5468\u671f\u8f83\u77ed\u3001\u5de5\u4f5c\u8f83\u96c6\u4e2d\uff0c\u56e0\u6b64\u4e00\u822c\u9009\u62e9\u8d76\u5de5\u8f83\u4e3a\u5408\u9002\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u5728\u8f83\u77ed\u65f6\u95f4\u5185\uff0c\u589e\u52a0\u4eba\u5458\uff0c\u5b89\u6392\u96c6\u4e2d\u5de5\u4f5c\uff0c\u53ef\u4ee5\u5feb\u901f\u5904\u7406\u5927\u91cf\u95ee\u9898\uff0c\u4ece\u800c\u8282\u7701\u65f6\u95f4\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">2.5 \u6210\u672c\u7ba1\u7406&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u6210\u672c\u7ba1\u7406\u4e5f\u662f\u9879\u76ee\u7ba1\u7406\u4e2d\u7684\u91cd\u8981\u56e0\u7d20\u3002\u4e0e\u8fdb\u5ea6\u4e00\u6837\uff0c \u5728\u9879\u76ee\u65e9\u671f\u9700\u8981\u5236\u5b9a\u521d\u6b65\u9884\u7b97\uff0c\u5e76\u5728\u5b9e\u65bd\u8fc7\u7a0b\u4e2d\u4e0d\u65ad\u8c03 \u6574\u9884\u7b97\u3002\u5e38\u7528\u7684\u9884\u7b97\u8bc4\u4f30\u65b9\u6cd5\u4e3a\u201c\u8d1d\u5854\u5206\u6790\u201d\uff0c\u5373\u6839\u636e\u7ecf \u9a8c\u6216\u5386\u53f2\u6570\u636e\u9884\u4f30\u51fa 3 \u4e2a\u6570\u503c \uff1a\u6700\u4e50\u89c2\u503c\u3001\u6700\u60b2\u89c2\u503c\u548c \u5e73\u5747\u503c\u3002\u7136\u540e\u8ba1\u7b97 \uff1a\u9884\u7b97 =(\u6700\u4e50\u89c2\u503c + \u6700\u60b2\u89c2\u503c +4 \u500d \u5e73\u5747\u503c)\/6\u3002\u5236\u5b9a\u9884\u7b97\u4e5f\u9700\u8981\u9884\u7559 20% \u7684\u7f13\u51b2\u989d\u5ea6\u3002 \u6210\u672c\u63a7\u5236\u8fc7\u7a0b\u4e2d\u9700\u8981\u6ce8\u610f\u201c\u9540\u91d1\u201d\u73b0\u8c61\u3002\u6240\u8c13\u201c\u9540\u91d1\u201d \u73b0\u8c61\u662f\u6307\u753b\u86c7\u6dfb\u8db3\uff0c\u591a\u6b64\u4e00\u4e3e\uff0c\u4ece\u800c\u4ea7\u751f\u4e0d\u5fc5\u8981\u7684\u6210\u672c\u589e\u52a0\u3002\u6210\u672c\u7ba1\u7406\u7684\u96be\u70b9\u5728\u4e8e\u63a7\u5236\u6210\u672c\u4e0d\u8d85\u51fa\u9884\u7b97\uff0c\u5176\u4e2d \u9632\u6b62\u201c\u9540\u91d1\u201d\u73b0\u8c61\u662f\u5173\u952e\u3002BE \u8bd5\u9a8c\u5e38\u89c1\u7684\u201c\u9540\u91d1\u201d\u73b0\u8c61 \u6709 \uff1a\u8fc7\u591a\u8bbe\u8ba1\u53d7\u8bd5\u8005\u4f8b\u6570 ;\u8fc7\u591a\u8bbe\u8ba1\u91c7\u8840\u70b9\u6570\u91cf ;\u8fc7\u591a \u589e\u52a0\u53d7\u8bd5\u8005\u4f4f\u9662\u5929\u6570 ;\u989d\u5916\u8fdb\u884c\u65b9\u6848\u5916\u68c0\u67e5 ;\u989d\u5916\u8fdb\u884c \u53d7\u8bd5\u8005\u8865\u52a9\u7b49\u3002\u56e0\u6b64 BE \u8bd5\u9a8c\u6574\u4e2a\u8fc7\u7a0b\u90fd\u5e94\u6ce8\u610f\u9632\u6b62\u201c\u9540 \u91d1\u201d\u73b0\u8c61\u7684\u51fa\u73b0\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">2.6 \u8d28\u91cf\u7ba1\u7406&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u8d28\u91cf\u7ba1\u7406\u8d2f\u7a7f\u6574\u4e2a\u9879\u76ee\u8fc7\u7a0b\uff0c\u5206\u4e3a\u8d28\u91cf\u4fdd\u8bc1(QA) \u548c\u8d28\u91cf\u63a7\u5236(QC)\u4e24\u90e8\u5206\u3002\u901a\u5e38\u8d28\u91cf\u4fdd\u8bc1\u662f\u9488\u5bf9\u7cfb\u7edf \u548c\u4f53\u7cfb\u800c\u8a00\uff0c\u8d28\u91cf\u63a7\u5236\u662f\u9488\u5bf9\u6267\u884c\u8fc7\u7a0b\u800c\u8a00\u3002\u8d28\u91cf\u7ba1\u7406 \u6709\u4e00\u4e2a\u8457\u540d\u7406\u8bba\uff0c\u5373 PDCA \u5faa\u73af\uff0cPDCA \u8fd9 4 \u4e2a\u82f1\u6587\u5b57 \u6bcd\u5206\u522b\u4ee3\u8868\u8ba1\u5212(plan)\u3001\u6267\u884c(do)\u3001\u68c0\u67e5(check)\u548c \u63aa\u65bd(action)\u3002PDCA \u5faa\u73af\u662f\u4e2a\u95ed\u73af\uff0c\u5728\u9879\u76ee\u8fd0\u884c\u8fc7\u7a0b \u4e2d\u8981\u6c42\u4e0d\u65ad\u5730\u5faa\u73af\u8fdb\u884c PDCA \u8fd9 4 \u4e2a\u52a8\u4f5c\uff0c\u5373\u5148\u5236\u5b9a\u8ba1 \u5212\uff0c\u6309\u7167\u8ba1\u5212\u6267\u884c\uff0c\u518d\u68c0\u67e5\u6267\u884c\u60c5\u51b5\u5e76\u53d1\u73b0\u95ee\u9898\uff0c\u6700\u540e \u91c7\u53d6\u63aa\u65bd\uff0c\u8fd4\u56de\u4fee\u8ba2\u8ba1\u5212\uff0c\u518d\u6b21\u5faa\u73af\u6267\u884c\u3002\u5982\u6b64\u5faa\u73af\u53ef \u6700\u5927\u5316\u5730\u4fdd\u8bc1\u9879\u76ee\u8d28\u91cf\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">BE \u8bd5\u9a8c\u4e5f\u9002\u7528\u201c\u8d28\u91cf\u4fdd\u8bc1 + \u8d28\u91cf\u63a7\u5236\u201d\u7ba1\u7406\u6a21\u5f0f\uff0c \u5373\u72ec\u7acb\u4e8e\u9879\u76ee\u5916\u7684\u4e13\u4eba\u8d1f\u8d23\u8d28\u91cf\u4fdd\u8bc1\u5de5\u4f5c\uff0c\u5728\u8bd5\u9a8c\u5f00\u59cb\u3001 \u6267\u884c\u3001\u7ed3\u675f\u671f\u95f4\u8d1f\u8d23\u8fdb\u884c\u7a3d\u67e5 ;\u9879\u76ee\u8d1f\u8d23\u4eba\u5728\u6574\u4e2a\u8bd5\u9a8c \u671f\u95f4\u8d1f\u8d23\u8fdb\u884c\u8d28\u91cf\u63a7\u5236\u3002\u5728\u7ba1\u7406\u8fc7\u7a0b\u4e2d\u6309\u7167 PDCA \u5faa\u73af\uff0c \u53ca\u65f6\u53d1\u73b0\u95ee\u9898\u5e76\u5236\u5b9a\u9884\u9632\u63aa\u65bd\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">2.7 \u98ce\u9669\u7ba1\u7406&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u98ce\u9669\u7ba1\u7406\u5e94\u8d2f\u7a7f\u6574\u4e2a\u9879\u76ee\u8fc7\u7a0b\uff0c\u662f\u6307\u7ba1\u7406\u53ef\u80fd\u53d1 \u751f\u4f46\u5c1a\u672a\u53d1\u751f\u7684\u95ee\u9898\u3002\u98ce\u9669\u7ba1\u7406\u9700\u8981\u6709\u4e00\u5b9a\u7ecf\u9a8c\u6216\u5386\u53f2 \u6570\u636e\u4f5c\u4e3a\u57fa\u7840\uff0c\u624d\u80fd\u5236\u5b9a\u51fa\u8f83\u5168\u9762\u7684\u7ba1\u7406\u8ba1\u5212\u548c\u5904\u7406\u63aa \u65bd\u3002\u98ce\u9669\u7ba1\u7406\u5e38\u7528\u7684\u624b\u6bb5\u4e3a\u7ea0\u6b63\u548c\u9884\u9632\u63aa\u65bd(corrective action &amp; preventive action\uff0cCAPA)\u8ffd\u8e2a\uff0c\u5373\u6839\u636e\u5df2\u53d1\u751f \u7684\u95ee\u9898\u9884\u6d4b\u5373\u5c06\u53d1\u751f\u7684\u98ce\u9669\uff0c\u5236\u5b9a\u9884\u9632\u63aa\u65bd\uff0c\u51cf\u5c11\u98ce\u9669 \u53d1\u751f\u7387\uff0c\u51cf\u8f7b\u98ce\u9669\u5f15\u53d1\u95ee\u9898\u7684\u5371\u5bb3\uff0c\u5e76\u5728\u9879\u76ee\u8fc7\u7a0b\u4e2d\u4e0d \u65ad\u66f4\u65b0\u548c\u8ddf\u8fdb\u3002 BE \u8bd5\u9a8c\u867d\u7136\u6a21\u5f0f\u76f8\u5bf9\u5355\u4e00\uff0c\u4f46\u5b58\u5728\u5404\u79cd\u4e0d\u786e\u5b9a\u56e0\u7d20\uff0c \u98ce\u9669\u9884\u6d4b\u96be\u5ea6\u5927\u3002\u901a\u5e38\u7684 BE \u8bd5\u9a8c\u98ce\u9669\u4e3a\uff1a\u53d7\u8bd5\u8005\u8d28\u91cf\u5dee\u3001 \u670d\u836f\u548c\u91c7\u8840\u65f6\u95f4\u8d85\u7a97\u3001\u8840\u6837\u4fdd\u5b58\u548c\u8fd0\u8f93\u6e29\u63a7\u4e0d\u8fbe\u6807\u3001\u53d7 \u8bd5\u8005\u8131\u843d\u7387\u9ad8\u3001\u8bd5\u9a8c\u836f\u54c1\u7ba1\u7406\u4e0d\u89c4\u8303\u7b49\u3002\u56e0\u6b64\u8981\u63d0\u524d\u505a \u597d\u9884\u9632\u63aa\u65bd\uff0c\u53ca\u65f6\u8ddf\u8fdb\uff0c\u624d\u80fd\u5c3d\u53ef\u80fd\u51cf\u5c11\u98ce\u9669\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">2.8 \u4eba\u5458\u4e0e\u6c9f\u901a\u7ba1\u7406&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u4eba\u5458\u4e0e\u6c9f\u901a\u7ba1\u7406\u867d\u4e0d\u662f\u9879\u76ee\u7ba1\u7406\u7684\u57fa\u7840\u201c\u94c1\u4e09\u89d2\u201d\uff0c \u4f46\u5374\u662f\u9879\u76ee\u7ba1\u7406\u6700\u5173\u952e\u548c\u6700\u96be\u7684\u90e8\u5206\uff0c\u56e0\u4e3a\u9879\u76ee\u80fd\u5426\u987a \u5229\u5f00\u5c55\uff0c\u80fd\u5426\u5982\u671f\u5b8c\u6210\uff0c\u9879\u76ee\u7ec4\u4eba\u5458\u7684\u914d\u5408\u548c\u6267\u884c\u662f\u5173\u952e\u3002 \u800c\u5927\u591a\u6570\u9879\u76ee\u7ba1\u7406\u8005\u5bf9\u7ec4\u5458\u4e0d\u5177\u5907\u76f4\u5c5e\u7ba1\u7406\u6743\u9650\uff0c\u56e0\u6b64 \u589e\u52a0\u4e86\u4eba\u5458\u7ba1\u7406\u548c\u6c9f\u901a\u7ba1\u7406\u7684\u96be\u5ea6\u3002 \u5728\u9879\u76ee\u521d\u671f\uff0c\u9879\u76ee\u7ba1\u7406\u8005\u8981\u5145\u5206\u4e89\u53d6\u6709\u5229\u4e8e\u9879\u76ee\u5f00 \u5c55\u7684\u5173\u952e\u4eba\u5458\uff0c\u5e76\u5236\u5b9a\u6c9f\u901a\u8ba1\u5212 ;\u5728\u9879\u76ee\u8fdb\u884c\u4e2d\uff0c\u8981\u5408 \u7406\u5206\u914d\u5de5\u4f5c\u4efb\u52a1\uff0c\u5145\u5206\u53d1\u6325\u5404\u4e2a\u7ec4\u5458\u7684\u4f18\u52bf ;\u540c\u65f6\u4e5f\u8981 \u5b9a\u671f\u4e0e\u7ec4\u5458\u8fdb\u884c\u6c9f\u901a\uff0c\u53ca\u65f6\u53d1\u73b0\u3001\u89e3\u51b3\u95ee\u9898\u3002 BE \u8bd5\u9a8c\u5de5\u4f5c\u91cf\u96c6\u4e2d\uff0c\u7ec6\u8282\u95ee\u9898\u548c\u4e0d\u786e\u5b9a\u56e0\u7d20\u591a\uff0c\u5bb9 \u6613\u5bfc\u81f4\u4eba\u5458\u3001\u4efb\u52a1\u7684\u5b89\u6392\u4ea7\u751f\u51b2\u7a81\uff0c\u56e0\u6b64\u9879\u76ee\u7ba1\u7406\u8005\u9700 \u8981\u5728\u9879\u76ee\u8fc7\u7a0b\u4e2d\u4e0d\u65ad\u5173\u6ce8\u4eba\u5458\u52a8\u6001\uff0c\u4fdd\u8bc1\u6c9f\u901a\u9891\u7387\uff0c\u4e00 \u822c\u6bcf\u5468\u6216\u6bcf\u6708\u53ec\u5f00\u9879\u76ee\u4f1a\u8bae\uff0c\u53ca\u65f6\u4e86\u89e3\u3001\u5904\u7406\u95ee\u9898\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">2.9 \u4f9b\u5e94\u5546\u4e0e\u5408\u540c\u7ba1\u7406&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u5728\u9879\u76ee\u7ba1\u7406\u4e2d\u4f9b\u5e94\u5546\u4e5f\u5c5e\u4e8e\u91cd\u8981\u7684\u5e72\u7cfb\u4eba\uff0c\u4e3b\u8981\u901a \u8fc7\u5408\u540c\u7684\u65b9\u5f0f\u8fdb\u884c\u7ba1\u7406\u3002\u5728\u5408\u540c\u4e2d\u8981\u660e\u786e\u76ee\u6807\u3001\u671f\u9650\u3001 \u8d39\u7528\u3001\u9a8c\u6536\u6807\u51c6\u548c\u8d23\u4efb\u5206\u5de5\u7b49\u5173\u952e\u4e8b\u9879\u3002\u533b\u836f\u4f01\u4e1a\u901a\u5e38 \u4e3a\u7532\u65b9\uff0c\u4f9b\u5e94\u5546\u4e3a\u4e59\u65b9 ;\u533b\u836f\u4f01\u4e1a\u7ecf\u5e38\u91c7\u7528\u201c\u603b\u4ef7\u5408\u540c\u201d \u5f62\u5f0f\uff0c\u5373\u5e38\u8bf4\u7684\u5927\u5305\uff0c\u603b\u8d39\u7528\u4e0d\u53d8\uff0c\u8d85\u989d\u8d39\u7528\u7531\u4e59\u65b9\u627f\u62c5\uff0c \u53ef\u5c06\u98ce\u9669\u8f6c\u5ac1\u7ed9\u4e59\u65b9\u3002 BE \u8bd5\u9a8c\u4e2d\u4e3b\u8981\u7684\u4f9b\u5e94\u5546\u5305\u62ec\u533b\u9662(\u8f83\u7279\u6b8a)\u3001\u751f\u7269 \u68c0\u6d4b\u516c\u53f8\u3001\u6570\u636e\u7ba1\u7406\u53ca\u7edf\u8ba1\u516c\u53f8\u3001\u4e34\u5e8a\u8bd5\u9a8c\u673a\u6784\u7ba1\u7406\u7ec4 \u7ec7(site management organization\uff0cSMO)\u3001\u4e34\u5e8a\u76d1\u67e5\u6216 \u7a3d\u67e5\u670d\u52a1\u516c\u53f8\u7b49\u3002\u9664\u533b\u9662\u5916\uff0c\u5176\u4ed6\u5173\u7cfb\u5747\u4e3a\u5408\u540c\u7814\u7a76\u7ec4 \u7ec7(contract research organization\uff0cCRO)\uff0c\u7531\u4e8e\u533b\u836f\u4f01 \u4e1a\u5904\u4e8e\u7532\u65b9\u5f3a\u52bf\u5730\u4f4d\uff0cCRO \u8f83\u5bb9\u6613\u7ba1\u7406\u3002\u4f46\u533b\u9662\u7531\u4e8e\u8d44 \u6e90\u7d27\u7f3a\uff0c\u533b\u751f\u5730\u4f4d\u8f83\u9ad8\uff0c\u867d\u4e3a\u5408\u540c\u4e59\u65b9\uff0c\u5b9e\u9645\u5904\u4e8e\u5f3a\u52bf \u5730\u4f4d\uff0c\u5bf9\u533b\u9662\u7684\u7ba1\u7406\u96be\u5ea6\u8f83\u5927\u3002\u56e0\u6b64\u5728\u533b\u9662\u7684\u7ba1\u7406\u4e0e\u6c9f \u901a\u4e2d\u9700\u8981\u628a\u63e1\u597d\u5206\u5bf8\uff0c\u5c3d\u91cf\u5b89\u6392\u7ecf\u9a8c\u4e30\u5bcc\u6216\u4e13\u4e1a\u77e5\u8bc6\u5bf9 \u7b49\u7684\u4eba\u5458\u8d1f\u8d23\uff0c\u4ee5\u51cf\u5c11\u6f5c\u5728\u969c\u788d\u548c\u98ce\u9669\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">2.10 \u9879\u76ee\u6536\u5c3e&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u9879\u76ee\u6536\u5c3e\u662f\u6307\u9879\u76ee\u7ed3\u9898\uff0c\u5305\u62ec\u6210\u679c\u9a8c\u6536\u3001\u6210\u679c\u79fb\u4ea4\u3001 \u8fc7\u7a0b\u8d44\u4ea7\u5b58\u6863\u3001\u9879\u76ee\u7ec4\u89e3\u6563\u3001\u5b8c\u6210\u6536\u5c3e\u7b49\u5de5\u4f5c\u5185\u5bb9\u3002\u82e5 \u9879\u76ee\u4e2d\u9014\u7ec8\u6b62\uff0c\u4e5f\u8981\u8fdb\u884c\u9879\u76ee\u7ed3\u9898\u3002 BE \u8bd5\u9a8c\u7684\u6536\u5c3e\u4e3b\u8981\u662f\u6307\u603b\u7ed3\u62a5\u544a\u9a8c\u6536\u548c\u5173\u95ed\u4e2d\u5fc3\u3002 \u82e5\u6709\u5de5\u4f5c\u5916\u5305\u7ed9 CRO\uff0c\u8fd8\u9700\u8981\u4e0e CRO \u8fdb\u884c\u8d44\u6599\u4ea4\u63a5\u548c \u8d39\u7528\u7ed3\u7b97\u7b49\u6536\u5c3e\u5de5\u4f5c\u3002\u5728\u5b9e\u9645\u4e2d\u5173\u95ed\u4e2d\u5fc3\u5f80\u5f80\u66f4\u590d\u6742\uff0c \u4f1a\u9047\u5230\u5404\u79cd\u7a81\u53d1\u95ee\u9898\u3002\u7531\u4e8e\u6bcf\u4e2a\u7814\u7a76\u4e2d\u5fc3\u7684\u8981\u6c42\u548c\u6d41\u7a0b \u4e0d\u540c\uff0c\u6240\u4ee5\u9700\u8981\u63d0\u524d\u4e0e\u7814\u7a76\u4e2d\u5fc3\u6c9f\u901a\u5173\u95ed\u4e2d\u5fc3\u6d41\u7a0b\u548c\u6ce8 \u610f\u4e8b\u9879\uff0c\u907f\u514d\u56e0\u6536\u5c3e\u4e0d\u5f53\u800c\u62d6\u5ef6\u8fdb\u5ea6\u3002 <br  \/><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\"><br  \/><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"color: rgb(255, 0, 0);\"><strong><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">3 \u76ee\u524d\u56fd\u5185 BE \u8bd5\u9a8c\u5e38\u89c1\u95ee\u9898\u53ca\u5206\u6790&nbsp;<\/span><\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">3.1 \u7814\u7a76\u4e2d\u5fc3\u8d44\u6e90\u5c11<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">&nbsp;\u201c7.22 \u4e8b\u4ef6\u201d\u548c\u201c\u4e00\u81f4\u6027\u8bc4\u4ef7\u201d\u5f15\u53d1\u4e86\u533b\u836f\u4f01\u4e1a\u5bf9 BE \u8bd5\u9a8c\u9700\u6c42\u91cf\u7684\u5267\u589e\u3002\u540c\u65f6\u7531\u4e8e\u6838\u67e5\uff0c\u90e8\u5206\u2160\u671f\u4e34\u5e8a\u8bd5 \u9a8c\u4e2d\u5fc3\u88ab\u6682\u505c\u8bd5\u9a8c\u6216\u53d6\u6d88\u8d44\u683c\u3002\u9020\u6210\u4e86\u6709\u7ecf\u9a8c\u7684 BE \u8bd5 \u9a8c\u4e2d\u5fc3\u4f9b\u4e0d\u5e94\u6c42\u3002\u53e6\u4e00\u65b9\u9762\uff0c\u5728\u653f\u7b56\u9f13\u52b1\u4e0b\uff0c\u65b0\u7684 BE \u673a\u6784\u4e5f\u5982\u96e8\u540e\u6625\u7b0b\u822c\u51fa\u73b0\uff0c\u4f46\u65b0\u6210\u7acb\u7684\u673a\u6784\u7ecf\u9a8c\u4e0d\u8db3\u3002 \u9488\u5bf9\u4ee5\u4e0a\u7279\u70b9\uff0c\u6211\u4eec\u5e94\u6839\u636e\u9879\u76ee\u96be\u6613\u7a0b\u5ea6\u5206\u7c7b\u7b5b\u9009 \u4e2d\u5fc3\u3002\u7b80\u5355\u7684\u9879\u76ee\uff0c\u5982\u9884\u8bd5\u9a8c\uff0c\u53ef\u59d4\u6258\u7ed9\u65b0\u673a\u6784\u3002\u53e6\u5916\uff0c \u5c3d\u91cf\u4e0d\u8981\u628a\u9879\u76ee\u59d4\u6258\u7ed9\u65b0\u673a\u6784\u4f5c\u4e3a\u7b2c\u4e00\u4e2a\u9879\u76ee ;\u590d\u6742\u7684 \u9879\u76ee\uff0c\u5982\u9ad8\u53d8\u5f02\u6216\u957f\u534a\u8870\u671f\u836f\u7269\uff0c\u5e94\u5c3d\u91cf\u59d4\u6258\u7ed9\u5df2\u6709\u540c \u7c7b\u8bd5\u9a8c\u7ecf\u9a8c\u7684\u8001\u673a\u6784\u3002\u7b5b\u9009\u4e2d\u5fc3\u65f6\uff0c\u4e0d\u4f46\u8981\u67e5\u770b\u786c\u4ef6\u8bbe\u65bd\uff0c \u66f4\u8981\u5173\u6ce8\u4eba\u5458\u914d\u7f6e\u3001\u9879\u76ee\u7ecf\u9a8c\u548c\u6807\u51c6\u5316\u64cd\u4f5c\u7a0b\u5e8f(standard operating procedure\uff0cSOP)\u7ba1\u7406\u4f53\u7cfb\u7b49\u8f6f\u56e0\u7d20\uff0c\u4ee5\u4fdd\u8bc1 \u8bd5\u9a8c\u987a\u5229\u5f00\u5c55\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">3.2 \u4e13\u4e1a\u4eba\u5458\u7d27\u7f3a&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u7531\u4e8e\u653f\u7b56\u4e8b\u4ef6\u5bfc\u81f4\u4e13\u4e1a BE \u8bd5\u9a8c\u4eba\u5458\u4e25\u91cd\u7d27\u7f3a\uff0c\u4e0d \u8bba\u533b\u836f\u4f01\u4e1a\u3001CRO \u8fd8\u662f\u8bd5\u9a8c\u4e2d\u5fc3\u90fd\u51fa\u73b0\u4e86\u201c\u4eba\u624d\u614c\u201d\u3002 \u4f5c\u4e3a\u9879\u76ee\u7ba1\u7406\u8005\uff0c\u4e00\u5b9a\u8981\u63d0\u524d\u4e0e\u7ba1\u7406\u5c42\u6c9f\u901a\uff0c\u5728\u9879 \u76ee\u5f00\u5c55\u524d\u62db\u52df\u5230\u6709\u7ecf\u9a8c\u7684\u4e13\u4e1a\u4eba\u5458 ;\u82e5\u5916\u90e8\u62db\u52df\u6709\u7ecf\u9a8c \u7684\u4eba\u5458\u96be\u5ea6\u8f83\u5927\uff0c\u5219\u5fc5\u987b\u5c3d\u5feb\u5efa\u7acb\u57f9\u8bad\u4f53\u7cfb\uff0c\u4ece\u5185\u90e8\u6216 \u5e94\u5c4a\u6bd5\u4e1a\u751f\u4e2d\u57f9\u517b BE \u8bd5\u9a8c\u4e13\u4e1a\u4eba\u5458\uff0c\u89e3\u51b3\u4eba\u5458\u7d27\u7f3a\u7684 \u95ee\u9898\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">3.3 \u9879\u76ee\u591a\uff0c\u65f6\u95f4\u5c11&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u7531\u4e8e\u653f\u7b56\u5bfc\u5411\uff0cBE \u8bd5\u9a8c\u96c6\u4e2d\u7206\u53d1\uff0c\u4e89\u76f8\u8d76\u5728\u653f\u7b56 \u7684\u622a\u6b62\u65e5\u671f\u524d\u5b8c\u6210\u8bd5\u9a8c\uff0c\u56e0\u6b64\u8fdb\u5ea6\u8981\u6c42\u975e\u5e38\u9ad8\u3002\u4f5c\u4e3a\u533b \u836f\u4f01\u4e1a\uff0c\u5e94\u9996\u5148\u5bf9 BE \u8bd5\u9a8c\u8fdb\u884c\u7acb\u9879\u8bc4\u4f30\uff0c\u4f18\u5316\u8d44\u6e90\u5206 \u914d\uff0c\u8bbe\u7f6e\u9879\u76ee\u4f18\u5148\u987a\u5e8f\uff0c\u6709\u5e8f\u5b89\u6392\u8bd5\u9a8c\u8fdb\u5ea6\uff0c\u53e6\u5916\uff0c\u53ef \u91c7\u7528\u9002\u5f53\u52a0\u73ed\u6216\u5b89\u6392\u591a\u9879\u76ee\u540c\u65f6\u5f00\u5c55\u7684\u65b9\u6cd5\uff0c\u4ee5\u8fbe\u5230\u6548 \u679c\u3002\u540c\u65f6\u5e94\u52a0\u5f3a\u98ce\u9669\u7ba1\u7406\uff0c\u63d0\u524d\u9884\u9632\u9650\u901f\u73af\u8282\u51fa\u73b0\u95ee\u9898\uff0c \u907f\u514d\u8fdb\u5ea6\u5ef6\u671f\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">3.4 \u6210\u672c\u5267\u589e&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u7531\u4e8e\u4f9b\u6c42\u5931\u8861\uff0c\u9020\u6210\u56fd\u5185 BE \u8bd5\u9a8c\u8d39\u7528\u4e0d\u65ad\u4e0a\u5347\uff0c \u76ee\u524d\u4e00\u9879 BE \u8bd5\u9a8c\u8d39\u7528\u5df2\u589e\u52a0\u6570\u5341\u500d\u3002\u4f5c\u4e3a\u533b\u836f\u4f01\u4e1a\uff0c \u53ef\u4ee5\u91c7\u53d6\u4e24\u79cd\u65b9\u5f0f\u964d\u4f4e\u6210\u672c \uff1a\u2460\u91c7\u7528\u603b\u4ef7\u5408\u540c\u5916\u5305\u7ed9 CRO \u516c\u53f8\uff0c\u53ef\u4ee5\u6709\u6548\u63a7\u5236\u6210\u672c ;\u2461\u591a\u5bb6\u7b5b\u9009 CRO \u6216\u8bd5 \u9a8c\u4e2d\u5fc3\uff0c\u9009\u62e9\u6027\u4ef7\u6bd4\u6700\u4f18\u8005\u5408\u4f5c\uff0c\u5c3d\u91cf\u7b7e\u7f72\u957f\u671f\u4f18\u60e0\u6761\u6b3e\uff0c \u964d\u4f4e\u6210\u672c\u3002\u53e6\u5916\uff0c\u5728\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u5fc5\u987b\u675c\u7edd\u201c\u9540\u91d1\u201d\u73b0\u8c61\uff0c \u9632\u6b62\u6210\u672c\u4e0d\u5408\u7406\u589e\u52a0\u3002&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">3.5 \u6cd5\u89c4\u66f4\u65b0\u5feb\uff0c\u5b9e\u9645\u8131\u8282&nbsp;<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u81ea\u4ece\u201c7.22 \u4e8b\u4ef6\u201d\u4ee5\u6765\uff0c\u56fd\u5bb6\u9881\u5e03\u7684\u65b0\u6cd5\u89c4\u63a5\u8e35\u800c\u81f3\uff0c \u4f46\u5b9e\u9645\u64cd\u4f5c\u8fc7\u7a0b\u4e2d\uff0c\u7814\u7a76\u8005\u591a\u5fd9\u4e8e\u8bd5\u9a8c\uff0c\u65e0\u6687\u5b66\u4e60\u548c\u91c7 \u7528\u65b0\u6cd5\u89c4\u7684\u8981\u6c42\uff0c\u9020\u6210\u4e86\u5b9e\u9645\u4e0e\u6cd5\u89c4\u7684\u8131\u8282\u3002\u56e0\u6b64\u4f5c\u4e3a \u533b\u836f\u4f01\u4e1a\uff0c\u5e94\u53ca\u65f6\u66f4\u65b0\u548c\u5b66\u4e60\u6cd5\u89c4\u77e5\u8bc6\uff0c\u5728\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d \u52a0\u5f3a\u5bf9\u7814\u7a76\u8005\u7684\u57f9\u8bad\uff0c\u53ca\u65f6\u66f4\u6b63\u9519\u8bef\u64cd\u4f5c\u4e60\u60ef\uff0c\u4fdd\u8bc1 BE \u8bd5\u9a8c\u7b26\u5408\u56fd\u5bb6\u6cd5\u89c4\u8981\u6c42\u3002 <br  \/><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\"><br  \/><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"color: rgb(255, 0, 0);\"><strong><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">4 \u7ed3\u8bed&nbsp;<\/span><\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">BE\u8bd5\u9a8c\u5728\u653f\u7b56\u5f15\u5bfc\u4e0b\u51fa\u73b0\u4e86\u7206\u53d1\u5f0f\u589e\u957f\uff0c\u4e5f\u56e0\u6b64 \u51fa\u73b0\u4e86\u5feb\u901f\u6539\u9769\uff0c\u4f46\u4ecd\u7136\u5b58\u5728\u8f83\u591a\u95ee\u9898\uff0c\u56e0\u6b64\u5e0c\u671b\u901a\u8fc7 \u9879\u76ee\u7ba1\u7406\u77e5\u8bc6\u63d0\u4f9b\u4e00\u4e9b\u89e3\u51b3\u95ee\u9898\u7684\u601d\u8def\u3002\u76ee\u524d\u56fd\u5185 BE \u8bd5\u9a8c\u5728\u6807\u51c6\u5316\u9879\u76ee\u7ba1\u7406\u65b9\u9762\u4ecd\u7136\u8584\u5f31\uff0c\u56e0\u6b64\uff0c\u4e5f\u5e0c\u671b\u4e0d \u65ad\u52a0\u5f3a\u9879\u76ee\u7ba1\u7406\u77e5\u8bc6\u7684\u666e\u53ca\uff0c\u4f7f\u56fd\u5185 BE \u8bd5\u9a8c\u7684\u7ba1\u7406\u66f4 \u52a0\u7b26\u5408\u56fd\u9645\u6807\u51c6\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\"><br  \/><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;clear: both;min-height: 1em;font-size: 14px;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: rgb(0, 0, 0);\">\u6765\u6e90\u4e0a\u6d77\u533b\u836f 2018\u5e74 \u7b2c39\u5377 \u7b2c9\u671f<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<p><br class=\"Apple-interchange-newline\"  \/><\/p>\n<p><br  \/><\/p>\n<p><br  \/><\/p>\n<p style=\"text-align: center;\"><span style=\"font-size: 20px;color: rgb(255, 0, 0);background-color: rgb(255, 251, 0);\"><strong>\u57f9\u8bad\u63a8\u8350<\/strong><\/span><\/p>\n<p style=\"text-align: center;\"><span style=\"color: rgb(64, 118, 0);font-size: 18px;\"><strong><a href=\"http:\/\/mp.weixin.qq.com\/s?__biz=MzU5NjUwOTgyNg==&amp;mid=2247491713&amp;idx=1&amp;sn=d5431dfdfff1dd5dc079f996a5738af3&amp;chksm=fe63356cc914bc7a52b82603e5caba42ba545d5a95632f85427d5b9ef83e3543d02fba07ef69&amp;scene=21#wechat_redirect\" target=\"_blank\">\u4e09\u5e74\u4e86\uff0c\u4e0e\u60a8\u6709\u4e2a\u7ea6\u4f1a<\/a><br  \/><\/strong><\/span><\/p>\n<p style=\"text-align: center;\"><a href=\"http:\/\/mp.weixin.qq.com\/s?__biz=MzU5NjUwOTgyNg==&amp;mid=2247491713&amp;idx=1&amp;sn=d5431dfdfff1dd5dc079f996a5738af3&amp;chksm=fe63356cc914bc7a52b82603e5caba42ba545d5a95632f85427d5b9ef83e3543d02fba07ef69&amp;scene=21#wechat_redirect\" target=\"_blank\"><span class=\"js_jump_icon h5_image_link\" style=\"top: auto;left: auto;right: auto;bottom: auto;\" ><\/span><\/a><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u9879\u76ee\u7ba1\u7406\u53ca\u5e38\u89c1\u95ee\u9898\u63a2\u8ba8&nbsp; \u6458 \u8981&nbsp;\u672c\u6587\u65e8\u5728\u4ee5\u9879\u76ee\u7ba1\u7406\u7684\u89d2\u5ea6\uff0c\u4ece\u6218\u7565\u4e00\u81f4\u6027\u3001\u9879 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":57845,"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\/57844"}],"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=57844"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57844\/revisions"}],"predecessor-version":[{"id":57847,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57844\/revisions\/57847"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/57845"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=57844"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=57844"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=57844"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}