{"id":77091,"date":"2018-12-26T00:00:50","date_gmt":"2019-02-01T06:02:23","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/77091\/"},"modified":"2019-02-01T14:02:41","modified_gmt":"2019-02-01T06:02:41","slug":"2852148a0c","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/77091\/","title":{"rendered":"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790"},"content":{"rendered":"
\n
<\/mpcps><\/section>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\u56fe<\/span><\/strong>1<\/strong>\uff1a\u6b27\u76df\u73b0\u573a\u68c0\u67e5\u5168\u7403\u4e0d\u7b26\u5408\u5de5\u5382\u56fd\u5bb6\u5206\u5e03<\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\u56fe2<\/span><\/strong>\uff1a\u4e0d\u7b26\u5408\u62a5\u544a\u6570\u91cf\u5728\u73b0\u573a\u68c0\u67e5\u4e2d\u7684\u5360\u6bd4<\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\u56fe3<\/span><\/strong>\uff1a<\/strong>\u53d1\u51fa\u4e0d\u7b26\u5408\u62a5\u544a\u7684\u5b98\u65b9\u673a\u6784\u5206\u5e03<\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n

\u56fe<\/span><\/strong>4<\/strong>\uff1a\u6536\u5230\u4e0d\u7b26\u5408\u62a5\u544a\u7684\u5de5\u5382\u7c7b\u578b\u5206\u5e03<\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n

\u56fe<\/span><\/strong>5<\/strong>\uff1a\u6b27\u76df\u5b98\u65b9\u68c0\u67e5\u65e5\u671f\u548c\u4e0d\u7b26\u5408\u62a5\u544a\u65e5\u671f\u5206\u5e03\u56fe<\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\u56fe<\/span><\/strong>6<\/strong>\uff1a\u6b27\u76df\u68c0\u67e5\u8d28\u91cf\u4f53\u7cfb\u7f3a\u9677\u9879\u76ee\u5206\u5e03\u56fe<\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n

\u56fe<\/span><\/strong>7<\/strong>\uff1a\u6b27\u76df\u68c0\u67e5\u8d28\u91cf\u4f53\u7cfb\u7f3a\u9677\u9879\u76ee\u5206\u5e03\u6bd4<\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\u56fe<\/span><\/strong>10. FDA<\/strong>\u5728\u56fd\u5185<\/strong>GMP<\/strong>\u68c0\u67e5\u7684\u7ed3\u679c\u5206\u7c7b<\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n

\u56fe<\/span><\/strong>11. FDA<\/strong>\u5728\u56fd\u5185<\/strong>GMP<\/strong>\u68c0\u67e5\u7684\u7ed3\u679c\u5360\u6bd4<\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/span><\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/span><\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/span><\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/span><\/strong><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/span><\/strong><\/p>\n

\u5728\u4e0a\u4e00\u5e74\u5ea6\u7684\u6c47\u603b\u662f\uff0c\u6211\u4eec\u63a8\u6d4b\u7531\u4e8e\u4e2d\u56fd\u5317\u65b926+2\u57ce\u5e02\u56e0\u4e3a\u51ac\u5b63\u91c7\u6696\u5b63\u8282\u653f\u5e9c\u8981\u6c42\u539f\u6599\u836f\u5316\u5de5\u4f01\u4e1a\u505c\u4ea7\u9650\u4ea7\uff0c11\u6708-3\u6708\u7684\u5317\u65b9\u4f01\u4e1a\u7684\u73b0\u573a\u68c0\u67e5\u53ef\u80fd\u4f1a\u5927\u5e45\u5ea6\u4e0b\u8c03\uff0c\u7f8e\u56fdFDA\u5317\u4eac\u529e\u516c\u5ba4\u4e5f\u53ef\u80fd\u4f1a\u56e0\u6b64\u51cf\u5c11\u73b0\u573a\u68c0\u67e5\u7684\u9891\u7387\uff0c\u5c06\u68c0\u67e5\u7684\u4e2d\u5fc3\u79fb\u5230\u4e2d\u56fd\u5357\u65b9\u4f01\u4e1a\u8eab\u4e0a\u3002\u4f46\u662f\u4ece\u886817\u4e2d\u7edf\u8ba1\u7684\u7ed3\u679c\u6765\u770b\uff0c\u5e76\u6ca1\u6709\u51fa\u73b0\u53bb\u5e74\u9884\u671f\u7684\u60c5\u51b5\u30022017.11.15-2018.3.15\u671f\u95f4\u7684\u88ab\u68c0\u67e5\u6570\u91cf\u548c\u5728\u6574\u4f53\u68c0\u67e5\u4e2d\u7684\u5360\u6bd4\u4e0e\u4e4b\u524d2\u5e74\u60c5\u51b5\u7c7b\u4f3c\uff0c\u5e76\u6ca1\u6709\u51fa\u73b0\u5f88\u5927\u7684\u53d8\u5316\u3002<\/span><\/p>\n


<\/p>\n

\u8868<\/strong>17. <\/span><\/strong>\u5317\u65b9\u57ce\u5e02\u5728\u505c\u4ea7\u9650\u4ea7\u88ab<\/strong>FDA<\/strong>\u68c0\u67e5\u7684\u9891\u7387<\/strong><\/span><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/strong><\/span><\/p>\n


<\/p>\n


<\/p>\n

\u56fe<\/strong>18. FDA<\/strong>\u5728\u56fd\u5185<\/strong>GMP<\/strong>\u68c0\u67e5\u7684\u7ed3\u679c\u5206\u7c7b\uff08<\/strong>2009<\/strong>\u5e74<\/strong>-2018<\/strong>\u5e74\uff09<\/strong><\/span><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n


<\/p>\n

(\u4e8c). 2018<\/strong>\u5e74FDA<\/strong>\u8b66\u544a\u4fe1\u6c47\u603b\u5206\u6790<\/strong><\/span><\/p>\n

\u7b14\u8005\u5206\u6790\u4e862017\u5e7412\u6708\u81f32018\u5e7411\u6708FDA\u53d1\u5e03\u7684\u8b66\u544a\u4fe1\uff0c\u5171\u53d1\u5e03\u4e8681\u5c01\u8b66\u544a\u4fe1\uff0c\u5bf9\u6bd4\u4e0a\u4e00\u5e74\u5ea6\u768463\u5c01\uff0c\u6570\u91cf\u589e\u52a0\u4e8628%\u3002\u8b66\u544a\u4fe1\u7684\u5177\u4f53\u5185\u5bb9\uff0c\u8bf7\u53c2\u89c1FDA\u5b98\u7f51\uff1a<\/span>https:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/default.htm\u3002\u672c\u6587\u5c06\u4f1a\u4ece\u88ab\u68c0\u67e5\u5de5\u5382\u6240\u5c5e\u56fd\u5bb6\u3001\u5236\u9020\u7c7b\u578b\u4ee5\u53ca\u4e3b\u8981\u7f3a\u9677\u5206\u5e03\u72b6\u51b5\u8fdb\u884c\u6c47\u603b\u5206\u6790\uff0c\u4ee5\u4f9b\u5927\u5bb6\u53c2\u8003\uff01<\/span><\/p>\n


<\/p>\n

81\u5c01\u8b66\u544a\u4fe1\u5206\u522b\u53d1\u7ed9\u4e8617\u4e2a\u4e0d\u540c\u56fd\u5bb6\u548c\u5730\u533a\u7684\u5de5\u5382\uff0c\u76f8\u6bd42015\u5e74\u5ea6\u76849\u56fd\u5bb6\u548c2017\u5e74\u5ea6\u768413\u4e2a\u56fd\u5bb6\uff0c\u5448\u73b0\u4e86\u6301\u7eed\u589e\u52a0\u548c\u8d8a\u53d1\u5206\u6563\u7684\u8d8b\u52bf\u3002\u6b64\u8d8b\u52bf\u548c\u53d1\u5e03\u8b66\u544a\u4fe1\u6570\u91cf\u589e\u52a0\u7684\u8d8b\u52bf\u76f8\u4e00\u81f4\u3002\u5728\u4e0a\u4e00\u5e74\u5ea62017\u5e74\u7684FDA\u8b66\u544a\u4fe1\u6c47\u603b\u5206\u6790\u4e2d\uff0c\u6211\u4eec\u63d0\u5230FDA\u5357\u7f8e\u529e\u516c\u5ba4\u6b63\u5f0f\u5f00\u59cb\u6295\u5165\u8fd0\u8425\uff0c\u731c\u6d4b\u5728\u58a8\u897f\u54e5\u3001\u5df4\u897f\u7b49\u5357\u7f8e\u56fd\u5bb6\u7684FDA\u68c0\u67e5\u9891\u7387\u4f1a\u5927\u5e45\u63d0\u5347\uff0c\u76f8\u5e94\u7684\u5357\u7f8e\u4f01\u4e1a\u62ff\u5230\u8b66\u544a\u4fe1\u7684\u6982\u7387\u4e5f\u53ef\u80fd\u4f1a\u5927\u5e45\u5ea6\u63d0\u5347\u3002\u4f46\u662f\u4ece\u76ee\u524d\u6c47\u603b\u7684\u6570\u636e\u6765\u770b\uff0c\u53bb\u5e74\u6211\u4eec\u731c\u6d4b\u7684\u60c5\u51b5\u5e76\u6ca1\u6709\u53d1\u751f\u3002\u9664\u4e86\u58a8\u897f\u54e5\u4f01\u4e1a\u7684\u68c0\u67e5\u9891\u7387\u4fdd\u6301\u4e0d\u53d8\uff0c\u5df4\u897f\u548c\u963f\u6839\u5ef7\u4f01\u4e1a\u7684\u68c0\u67e5\u9891\u7387\u8fd8\u964d\u4f4e\u4e86\u30022018\u5e74\u58a8\u897f\u54e5\u4f01\u4e1a\u62ff\u5230\u4e863\u5c01\u8b66\u544a\u4fe1\uff0c\u5176\u4e2d2\u5c01\u7ed9\u4e86OTC\u4f01\u4e1a\uff0c\u53ea\u80fd\u8bf4\u660eFDA\u9075\u5faa\u81ea\u5df1\u7684\u98ce\u63a7\u6a21\u578b\u9009\u62e9\u4e86\u66f4\u591a\u9ad8\u98ce\u9669\u7684OTC\u4f01\u4e1a\u8fdb\u884c\u68c0\u67e5\u7684\u7ed3\u679c\u3002\u5177\u4f53\u6570\u636e\u8bf7\u89c1\u886819\u3002<\/span><\/p>\n


<\/p>\n

\u8868<\/strong>19. <\/span><\/strong>\u4e2d\u5357\u7f8e\u6d32\u56fd\u5bb6\u68c0\u67e5\u6570\u91cf\u548c\u8b66\u544a\u4fe1\u6bd4\u4f8b<\/strong><\/span><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n

\u5907\u6ce8<\/span><\/p>\n

1. \u53ea\u7edf\u8ba1CDER\u548cCVM\u8fdb\u884c\u7684GMP\u68c0\u67e5\u3002<\/span><\/p>\n

2. \u7531\u4e8e\u8b66\u544a\u4fe1\u7684\u5f00\u5177\u548cFDA\u5b98\u7f51\u68c0\u67e5\u7ed3\u679c\u7684\u516c\u5e03\u6709\u65f6\u95f4\u5ef6\u8fdf\uff0c\u8b66\u544a\u4fe1\u6bd4\u4f8b\u662f\u7528\u540e\u4e00\u5e74\u7684\u8b66\u544a\u4fe1\u6570\u91cf\u9664\u4ee5\u5f53\u5e74\u7684\u68c0\u67e5\u6570\u91cf\u5f97\u5230\u3002<\/span><\/p>\n


<\/p>\n

\u4ece\u56fe20\u4e2d\u53ef\u4ee5\u770b\u5230\uff0c\u6392\u540d\u524d\u56db\u7684\u7f8e\u56fd\u3001\u4e2d\u56fd\u3001\u5370\u5ea6\u548c\u97e9\u56fd\u7684\u5de5\u5382\u5171\u5f97\u523053\u5c01\u8b66\u544a\u4fe1\uff0c\u76f8\u6bd4\u53bb\u5e74\u524d\u56db\u540d\u56fd\u5bb6\u768452\u5c01\uff0c\u6570\u91cf\u4e0a\u6ca1\u6709\u589e\u52a0\u3002\u66f4\u7531\u4e8e\u8b66\u544a\u4fe1\u603b\u6570\u7684\u589e\u52a0\uff0c\u5360\u6240\u6709\u8b66\u544a\u4fe1\u7684\u6bd4\u91cd\u4ece2017\u5e74\u5ea6\u768478%\u4e0b\u964d\u5230\u4e8665%\u3002\u7f8e\u4e2d\u5370\u4e09\u56fd\u4f5c\u4e3a\u8001\u724c\u9738\u699c\u7684\u56fd\u5bb6\uff0c\u4e00\u5982\u65e2\u5f80\u7684\u5360\u636e\u7684\u524d\u4e09\u540d\u3002\u5f53\u7136\u4e5f\u6709\u65b0\u8d35\uff0c\u97e9\u56fd\u6210\u529f\u8d85\u8d8a\u52a0\u62ff\u5927\uff0c\u722c\u5347\u5230\u4e86\u7b2c\u56db\u3002<\/span><\/p>\n


<\/p>\n

\u56fe<\/strong>20. <\/span><\/strong>\u6536\u5230\u8b66\u544a\u4fe1\u5de5\u5382\u7684\u56fd\u5bb6\u548c\u5730\u533a\u5206\u5e03<\/strong><\/span><\/p>\n

\"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n


<\/p>\n

\u4e0b\u9762\u7b14\u8005\u5c06\u9010\u4e00\u5206\u6790\u8fd9\u56db\u4e2a\u56fd\u5bb6\u5de5\u5382\u6536\u5230\u8b66\u544a\u4fe1\u7684\u60c5\u51b5\uff1a<\/span><\/p>\n

    \n
  1. \n

    \u4ece\u886821\u53ef\u4ee5\u770b\u5230\uff0c\u4e2d\u56fd\u5de5\u5382\u62ff\u5230\u8b66\u544a\u4fe1\u7684\u6bd4\u4f8b\u548c\u6b27\u7f8e\u53d1\u8fbe\u56fd\u5bb6\u76f8\u6bd4\u8fd8\u662f\u504f\u9ad8\u7684\u3002\u57282017\u5e74\u5ea6\u73b0\u573a\u68c0\u67e5\u6570\u91cf\uff08144\u6b21\uff09\u6bd42016\u5e74\u5ea6\uff08204\u6b21\uff09\u964d\u4f4e\u7684\u524d\u63d0\u4e0b\uff0c\u8b66\u544a\u4fe1\u6bd4\u4f8b\u6709\u589e\u52a0\u7684\u8d8b\u52bf\u3002\u5728\u5177\u4f53\u5206\u67902018\u5e74\u53d1\u5e03\u7684\u8fd917\u5c01\u8b66\u544a\u4fe1\uff0c\u5176\u4e2d\u67097\u5c01\u662f\u5f00\u5177\u7ed9\u751f\u4ea7OTC\u5236\u5242\u836f\u54c1\u7684\u516c\u53f8\u7684\uff0c\u5176\u4e2d\u6709\u4e00\u5bb6\u751a\u81f3\u662f\u751f\u4ea7\u65e0\u83ccOTC\u5236\u5242\u7684\u3002\u8fd97\u5bb6\u516c\u53f8\u57fa\u672c\u90fd\u662f\u6ca1\u6709\u6b27\u7f8eGMP\u7ba1\u7406\u7ecf\u9a8c\u7684\u5316\u5986\u54c1\u3001\u65e5\u7528\u54c1\u548c\u79d1\u6280\u516c\u53f8\uff0c\u6240\u4ee5\u5f97\u5230\u8b66\u544a\u4fe1\u4e5f\u662f\u5f88\u6b63\u5e38\u7684\u4e00\u4ef6\u4e8b\u3002\u6309\u7167\u7b14\u8005\u7684\u7ecf\u9a8c\uff0c\u8fd9\u7c7b\u516c\u53f8\u6709\u5f88\u591a\u4e0d\u660e\u767dFDA\u5bf9\u4e8eOTC\u4ea7\u54c1\u7684\u5206\u7c7b\u548cGMP\u8981\u6c42\uff0c\u6216\u8005\u5c31\u662f\u88ab\u8d38\u6613\u5546\u5ffd\u60a0\u800c\u8fdb\u5165\u4e86\u7f8e\u56fd\u5e02\u573a\u3002\u5228\u53bb\u8fd9\u4e9bOTC\u4ea7\u54c1\u518d\u6765\u770b\uff0c\u5269\u4f59\u768410\u5bb6\u516c\u53f8\u4e2d\uff0c\u8fd8\u662f\u4f20\u7edf\u7684API\u751f\u4ea7\u4f01\u4e1a\u5360\u591a\u6570\uff087\u5bb6\uff09\uff0c\u800c\u4e14\u6709\u4e0d\u5c11\u662f\u884c\u4e1a\u5185\u4eba\u58eb\u90fd\u719f\u6089\u7684\u516c\u53f8\u3002<\/span><\/p>\n<\/li>\n

  2. \n

    \u7f8e\u56fd\u5de5\u5382\u867d\u7136\u62ff\u5230\u7684\u8b66\u544a\u4fe1\u6570\u91cf\u591a\uff0c\u4f46\u662f\u90a3\u662f\u56e0\u4e3aFDA\u7684\u68c0\u67e5\u603b\u6570\u91cf\u591a\uff0c\u4ece\u6bd4\u4f8b\u4e0a\u770b\u7f8e\u56fd\u662f\u62ff\u8b66\u544a\u4fe1\u6700\u591a\u7684\u524d10\u4e2a\u56fd\u5bb6\u4e2d\u6700\u4f4e\u7684\uff0c\u8bf4\u660e\u7f8e\u56fd\u5236\u836f\u4f01\u4e1a\u7684\u6574\u4f53GMP\u7ba1\u7406\u6c34\u5e73\u8fd8\u662f\u4e0d\u9519\u7684\u3002\u4e0d\u8fc7\uff0c\u6211\u4eec\u5728\u8fd9\u91cc\u6ca1\u6709\u7edf\u8ba1\u7f8e\u56fd\u836f\u623f\u5236\u5242\u516c\u53f8\u7684\u8b66\u544a\u4fe1\u60c5\u51b5\u3002\u7531\u4e8e\u836f\u623f\u5236\u5242\u539f\u6765\u4e0d\u5728FDA\u7684\u76d1\u7ba1\u8303\u56f4\u5185\uff0c\u8fd1\u51e0\u5e74\u624d\u5f00\u59cb\u88abFDA\u68c0\u67e5\uff0c\u5176\u8b66\u544a\u4fe1\u7684\u6bd4\u4f8b\u6bd4\u5e38\u89c4\u5236\u836f\u4f01\u4e1a\u9ad8\u5f97\u591a\u3002<\/span><\/p>\n<\/li>\n

  3. \n

    \u4ece\u886821\u4e2d\u53ef\u4ee5\u660e\u663e\u770b\u5230\uff0c\u5370\u5ea6\u5de5\u5382\u6536\u5230\u8b66\u544a\u4fe1\u7684\u6570\u91cf\u548c\u6bd4\u4f8b\u6709\u4e0b\u964d\u7684\u8d8b\u52bf\u3002\u5bf9\u6bd4\u4e2d\u56fd\u5de5\u5382\u7684\u4e0a\u5347\u8d8b\u52bf\uff0c\u4e24\u56fd\u4e4b\u95f4\u7684\u6bd4\u4f8b\u5dee\u8ddd\u57282017\u5e74\u5ea6\u62c9\u5927\u5230\u4e00\u500d\u5de6\u53f3\u3002\u4ed4\u7ec6\u7814\u7a76\u4e00\u4e0b\u8fd99\u4e2a\u5de5\u5382\uff0c\u751f\u4ea7OTC\u5236\u5242\u836f\u54c1\u7684\u5de5\u5382\u53ea\u67092\u5bb6\uff0c\u5728\u8b66\u544a\u4fe1\u4e2d\u7684\u6bd4\u4f8b\u6bd4\u4e2d\u56fd\u4f01\u4e1a\u5c11\u7684\u591a\u3002\u8fd9\u662f\u5728\u68c0\u67e5\u6b21\u6570\u76f8\u5f53\u7684\u60c5\u51b5\u4e0b\uff0c\u5370\u5ea6\u4f01\u4e1a\u6574\u4f53\u8b66\u544a\u4fe1\u6570\u91cf\u6bd4\u4e2d\u56fd\u5c11\u7684\u4e00\u4e2a\u5f88\u91cd\u8981\u7684\u539f\u56e0\u3002\u7b14\u8005\u731c\u6d4b\u6570\u636e\u5b8c\u6574\u6027\u65b9\u9762\u5408\u89c4\u6027\u7684\u63d0\u9ad8\uff0c\u5f88\u53ef\u80fd\u662f\u5370\u5ea6\u4f01\u4e1a\u8b66\u544a\u4fe1\u6570\u91cf\u51cf\u5c11\u7684\u53e6\u4e00\u4e2a\u539f\u56e0\u3002\u81ea2012\u5e74Peter Baker\u6380\u8d77\u7684\u6570\u636e\u5b8c\u6574\u6027\u98ce\u66b4\u5df2\u7ecf\u5230\u4e86\u7b2c\u516d\u4e2a\u5e74\u5934\uff0c\u5370\u5ea6\u7684\u4e2d\u5927\u578b\u4f01\u4e1a\u57fa\u672c\u5df2\u7ecf\u7406\u89e3\u4e86FDA\u5bf9\u4e8e\u6570\u636e\u5b8c\u6574\u6027\u7684\u671f\u671b\uff0c\u5e76\u9002\u5e94\u4e86\u76f8\u5e94\u7684\u76d1\u7ba1\u65b9\u5f0f\u3002\u6240\u4ee5\u867d\u7136\u4eca\u5e74\u5370\u5ea6\u4f01\u4e1a\u7684\u8b66\u544a\u4fe1\u4e2d\u8fd8\u662f\u6709\u8d85\u8fc7\u4e00\u534a\uff085\u5c01\uff09\u7684\u548c\u6570\u636e\u5b8c\u6574\u6027\u6709\u5173\uff0c\u4f46\u662f\u5df2\u7ecf\u6ca1\u6709\u719f\u6089\u7684\u516c\u53f8\u540d\u5b57\u4e86\uff0c\u57fa\u672c\u4e0a\u90fd\u662f\u4e00\u4e9b\u5c0f\u516c\u53f8\u4e86\u3002<\/span><\/p>\n<\/li>\n

  4. \n

    \u97e9\u56fd\u4f01\u4e1a\u51fa\u4e4e\u610f\u6599\u5730\u5360\u636e\u4e86\u7b2c\u56db\u4f4d\uff0c2018\u5e74\u5ea6\u88ab\u53d1\u5e03\u8b66\u544a\u4fe1\u7684\u6570\u91cf\u8fbe\u52308\u5c01\u3002\u7a81\u7136\u7206\u53d1\u51fa\u8fd9\u4e48\u591a\u8b66\u544a\u4fe1\uff0c\u7b14\u8005\u8ba4\u4e3a\u4e3b\u8981\u56e0\u4e3a\u4ee5\u4e0b2\u4e2a\u539f\u56e0\u3002\u7b2c\u4e00\uff0cFDA\u57282017\u5e74\u660e\u663e\u7684\u589e\u52a0\u4e86\u5bf9\u4e8e\u97e9\u56fd\u4f01\u4e1a\u7684\u73b0\u573a\u68c0\u67e5\u6570\u91cf\u3002\u4ece\u886821\u4e2d\u53ef\u4ee5\u770b\u5230\uff0cFDA\u68c0\u67e5\u97e9\u56fd\u4f01\u4e1a\u7684\u6570\u91cf\u4ece2016\u5e74\u5ea6\u768410\u5bb6\uff0c\u589e\u52a0\u5230\u4e8653\u5bb6\u3002\u7b2c\u4e8c\uff0c\u5f88\u6709\u97e9\u56fd\u836f\u4f01\u51fa\u53e3\u5230\u7f8e\u56fd\u7684\u4ea7\u54c1\u90fd\u662f\u9ad8\u98ce\u9669\u7684\u4ea7\u54c1\u3002\u6536\u5230\u8b66\u544a\u4fe18\u5bb6\u4f01\u4e1a\u7684\u7c7b\u578b\u57fa\u672c\u5206\u4e3a2\u5927\u7c7b\uff0cOTC\u5236\u5242\uff085\u5bb6\uff09\u548c\u65e0\u83cc\u5236\u5242\uff082\u5bb6\uff09\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


    <\/p>\n

    \u5176\u5b83\u6536\u5230\u8b66\u544a\u4fe1\u8f83\u591a\u7684\u56fd\u5bb6\u4e2d\uff0c\u6709\u4e00\u4e9b\u662f\u6bd4\u8f83\u503c\u5f97\u5173\u6ce8\u7684\u3002\u65e5\u672c\u76843\u5bb6\u4f01\u4e1a\u90fd\u662f\u56e0\u4e3a\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u5f97\u5230\u7684\u8b66\u544a\u4fe1\uff0c\u7531\u6b64\u53ef\u89c1\u65e5\u672c\u4f01\u4e1a\u5728\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u4e0a\u7684\u5408\u89c4\u6027\u8fd8\u662f\u6709\u5dee\u8ddd\u7684\u3002<\/span><\/p>\n


    <\/p>\n

    \u8868<\/strong>21<\/strong>\uff1a\u68c0\u67e5\u6570\u91cf\u548c\u8b66\u544a\u4fe1\u6bd4\u4f8b<\/strong><\/span><\/p>\n

    \"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n

    \u5907\u6ce8\uff1a
    1. \u9664\u7f8e\u56fd\u5916\u7684\u5176\u4ed6\u56fd\u5bb6\uff0c\u7edf\u8ba1CDER\u548cCVM\u8fdb\u884c\u7684GMP\u68c0\u67e5\u3002\u62ec\u53f7\u4e2d\u7684\u4e3aCVM\u68c0\u67e5\u6570\u91cf\u3002<\/span><\/p>\n

    2. \u7531\u4e8e\u7f8e\u56fd\u6709\u5927\u91cfCVM\u5bf9\u4e8e\u517d\u836f\u7684\u68c0\u67e5\uff0c\u6240\u4ee5\u628a\u517d\u836f\u90e8\u5206\u6392\u9664\u5728\u5916\uff0c\u53ea\u7edf\u8ba1CDER\u8fdb\u884c\u4e86GMP\u68c0\u67e5\u3002<\/span><\/p>\n

    3. \u6ca1\u6709\u7edf\u8ba1\u7f8e\u56fd\u836f\u623f\u5236\u5242\uff08Compounding\uff09\u516c\u53f8\u7684\u68c0\u67e5\u6570\u636e<\/span><\/p>\n

    4. \u7531\u4e8e\u8b66\u544a\u4fe1\u7684\u5f00\u5177\u548cFDA\u5b98\u7f51\u68c0\u67e5\u7ed3\u679c\u7684\u516c\u5e03\u6709\u65f6\u95f4\u5ef6\u8fdf\uff0c\u8b66\u544a\u4fe1\u6bd4\u4f8b\u662f\u7528\u540e\u4e00\u5e74\u7684\u8b66\u544a\u4fe1\u6570\u91cf\u9664\u4ee5\u5f53\u5e74\u7684\u68c0\u67e5\u6570\u91cf\u5f97\u5230\u3002<\/span><\/p>\n


    <\/p>\n

    81\u5bb6\u6536\u5230\u8b66\u544a\u4fe1\u7684\u4f01\u4e1a\u4e2d\uff0c19\u5bb6\u662fAPI\u751f\u4ea7\u4f01\u4e1a\u548c61\u5bb6\u5236\u5242\u751f\u4ea7\u4f01\u4e1a\uff0c\u5236\u5242\u4f01\u4e1a\u7684\u6bd4\u4f8b\u4ece\u53bb\u5e74\u768469.3%\u8fdb\u4e00\u6b65\u6269\u5927\u523075.3%\u3002\u518d\u5206\u6790\u4e00\u4e0b\u8fd961\u5bb6\u5236\u5242\u751f\u4ea7\u4f01\u4e1a\u7684\u7ec4\u6210\uff0c\u5176\u4e2d\u670937\u5bb6\u4e3aOTC\u5236\u5242\u751f\u4ea7\u4f01\u4e1a\uff0c9\u5bb6\u4e3a\u65e0\u83cc\u5236\u5242\u751f\u4ea7\u4f01\u4e1a\uff0c\u5206\u522b\u5360\u6bd460.6%\u548c14.8%\u3002\u6263\u96641\u5bb6\u91cd\u53e0\u7684\u4f01\u4e1a\uff0c\u8fd92\u7c7b\u4f01\u4e1a\u5360\u6240\u6709\u5236\u5242\u751f\u4ea7\u4f01\u4e1a\u7684\u6bd4\u91cd\u4e3a73.8%\u3002\u660e\u663e\u53ef\u4ee5\u63a8\u6d4b\uff0cFDA\u7684\u5185\u90e8\u98ce\u63a7\u7cfb\u7edf\u4e2d\uff0c\u5c06OTC\u4ea7\u54c1\u548c\u65e0\u83cc\u4ea7\u54c1\u5217\u4e3a\u4e86\u9ad8\u98ce\u9669\u7684\u4ea7\u54c1\uff0c\u56e0\u6b64\u589e\u52a0\u4e86\u5bf9\u4e8e\u6b642\u7c7b\u4ea7\u54c1\u751f\u4ea7\u4f01\u4e1a\u7684\u68c0\u67e5\u8303\u56f4\u548c\u9891\u7387\u3002\u5728\u62ff\u5230\u591a\u5c01\u8b66\u544a\u4fe1\u7684\u56fd\u5bb6\u548c\u5730\u533a\u4e2d\uff0c\u9999\u6e2f\u548c\u53f0\u6e7e\u662f\u5f88\u5178\u578b\u7684\u4f8b\u5b50\u3002 \u9999\u6e2f\u5730\u533a\u76843\u5bb6\u4f01\u4e1a\u90fd\u662fOTC\u4ea7\u54c1\uff082\u4e2a\u5236\u5242\uff0c1\u4e2aAPI\uff09\uff0c\u53f0\u6e7e\u5730\u533a\u76842\u5bb6\u5de5\u5382\uff0c\u5206\u522b\u662fOTC\u5236\u5242\u5de5\u5382\u548c\u65e0\u83cc\u5236\u5242\u5de5\u5382\u3002\u4e0e\u7f8e\u56fd\u6d77\u5173\u4e4b\u95f4\u7684\u5408\u4f5c\uff0c\u5e2e\u52a9FDA\u83b7\u53d6\u8fdb\u53e3\u836f\u54c1\u7684\u6570\u636e\uff0c\u5bf9\u4e8eFDA\u8bc4\u4f30OTC\u4ea7\u54c1\u548c\u4f01\u4e1a\u7684\u98ce\u9669\u5e2e\u52a9\u5f88\u5927\u3002\u8d8a\u6765\u8d8a\u591a\u4e16\u754c\u5404\u5730\u7684OTC\u751f\u4ea7\u4f01\u4e1a\uff0c\u56e0\u4e3a\u6709\u836f\u54c1\u8fdb\u53e3\u7684\u6d77\u5173\u6570\u636e\u800c\u88abFDA\u9996\u6b21\u68c0\u67e5\u3002\u7b14\u8005\u731c\u6d4b\u968f\u7740\u8fd9\u4e48\u9ad8\u6bd4\u4f8b\u8fd92\u7c7b\u8b66\u544a\u4fe1\u5382\u5bb6\u7684\u51fa\u73b0\uff0cFDA\u52bf\u5fc5\u4f1a\u5728\u98ce\u63a7\u4f53\u7cfb\u4e2d\u7ee7\u7eed\u52a0\u5927\u8fd92\u7c7b\u4ea7\u54c1\u4f01\u4e1a\u7684\u98ce\u9669\u8d4b\u503c\uff0c\u52a0\u5927\u5bf9\u4e8e\u8fd9\u7c7b\u4f01\u4e1a\u7684\u68c0\u67e5\u3002\u7b14\u8005\u4e5f\u4f1a\u6301\u7eed\u5173\u6ce8\u8fd9\u4e2a\u8d8b\u52bf\uff0c\u5728\u660e\u5e74\u7684\u6c47\u603b\u4e2d\u7ee7\u7eed\u8ba8\u8bba\u3002<\/span><\/p>\n


    <\/p>\n

    \u56fe<\/strong>22. <\/span><\/strong>\u6536\u5230\u8b66\u544a\u4fe1\u7684\u5de5\u5382\u7c7b\u578b\u5206\u5e03<\/strong><\/span><\/p>\n

    \"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n


    <\/p>\n

    \u5206\u6790\u5b8c\u6536\u5230\u8b66\u544a\u4fe1\u7684\u5236\u5242\u4f01\u4e1a\uff0c\u6211\u4eec\u518d\u6765\u770bAPI\u4f01\u4e1a\u30022017\u5e74\u6536\u5230\u8b66\u544a\u4fe1\u768418\u5bb6API\u4f01\u4e1a\uff0c\u4e2d\u56fd\u548c\u5370\u5ea6\u54049\u5bb6\uff0c\u53ef\u8c13\u5e73\u5206\u79cb\u8272\u30022018\u5e74\u5ea6\uff0c\u6536\u5230\u8b66\u544a\u4fe1API\u4f01\u4e1a\u660e\u663e\u5448\u73b0\u5206\u6563\u7684\u8d8b\u52bf\u300219\u5206\u8b66\u544a\u4fe1\u53d1\u5e03\u7ed9\u4e868\u4e2a\u56fd\u5bb6\uff0c\u904d\u5e03\u5317\u7f8e\u3001\u6b27\u6d32\u548c\u4e9a\u6d32\u3002\u5177\u4f53\u6570\u636e\u8bf7\u770b\u56fe23\u3002\u4e2d\u56fdAPI\u4f01\u4e1a\u6536\u5230\u7684\u8b66\u544a\u4fe1\u6570\u91cf\u6700\u591a\uff0c\u548c2017\u5e74\u5ea6\u76849\u5c01\u5dee\u8ddd\u4e0d\u5927\u3002\u5728FDA\u5bf9\u4e2d\u56fd\u4f01\u4e1a\u6574\u4f53\u68c0\u67e5\u6570\u91cf\u51cf\u5c11\u7684\u60c5\u51b5\u4e0b\uff0c\u5b9e\u9645\u6bd4\u4f8b\u662f\u63d0\u9ad8\u4e86\u3002\u5230\u5e95\u662f\u56e0\u4e3aFDA\u98ce\u63a7\u4f53\u7cfb\u4f18\u79c0\uff0c\u8fd8\u662f\u4e2d\u56fd\u4f01\u4e1a\u7684GMP\u7ba1\u7406\u6c34\u5e73\u7684\u63d0\u5347\u6ca1\u6709\u8ddf\u4e0aFDA\u76d1\u7ba1\u6807\u51c6\u7684\u63d0\u9ad8\uff0c\u503c\u5f97\u6211\u4eec\u5404\u4f4dAPI\u884c\u4e1a\u7684\u540c\u884c\u601d\u8003\u3002<\/span><\/p>\n


    <\/p>\n

    \u56fe<\/strong>23. API<\/strong>\u5de5\u5382\u8b66\u544a\u4fe1\u56fd\u5bb6\u5206\u5e03<\/strong><\/span><\/p>\n

    \"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n


    <\/p>\n

    \u56fe24\u4e2d\u6c47\u603b\u5206\u6790\u4e862017-2018\u5e74\u5ea6\u68c0\u67e5\u65f6\u95f4\u548c\u8b66\u544a\u4fe1\u53d1\u5e03\u65f6\u95f4\u4e4b\u95f4\u7684\u95f4\u9694\u3002\u548c2016-2017\u5e74\u5ea6\u65f6\u7684\u60c5\u51b5\u4e0d\u540c\uff0cFDA\u4ece\u68c0\u67e5\u7ed3\u675f\u5230\u53d1\u5e03\u8b66\u544a\u4fe1\u7684\u65f6\u95f4\u95f4\u9694\u6574\u4f53\u4e0a\u6ca1\u6709\u518d\u8fdb\u4e00\u6b65\u7f29\u77ed\u7684\u8d8b\u52bf\uff0c\u5df2\u7ecf\u57fa\u672c\u7a33\u5b9a\u57286\u4e2a\u6708\u5de6\u53f3\u3002\u65f6\u95f4\u95f4\u9694\u6700\u957f\u7684\u662f\u53d1\u7ed9Tris Pharma Inc.\u7684\u8b66\u544a\u4fe1\uff0cFDA\u57282017\u5e743\u670820\u65e5\u5c31\u5b8c\u6210\u4e86\u5bf9\u8be5\u5382\u7684\u68c0\u67e5\uff0c\u4f46\u662f\u8b66\u544a\u4fe1\u76f4\u52302018\u5e743\u670826\u65e5\u624d\u53d1\u5e03\uff0c\u65f6\u95f4\u95f4\u9694\u8d85\u8fc7\u4e86\u4e00\u5e74\uff0c\u4f46\u662f\u6bd42016\u5e74\u5ea6\u6700\u957f\u65f6\u95f4\u95f4\u9694\u76841\u5e74\u534a\u5df2\u7ecf\u7f29\u77ed\u4e86\u3002\u800c2017\u5e749\u670822\u65e5FDA\u68c0\u67e5\u4e86Wong Lap Kwong Medicine Company Limited\uff0c\u4e0d\u52304\u4e2a\u6708\u65f6\u5c31\u53d1\u5e03\u4e86\u76f8\u5173\u7684\u8b66\u544a\u4fe1\u3002FDA\u5df2\u7ecf\u5728GDUFA II\u4e2d\u627f\u8bfa\uff0c\u4ece2018\u5e7410\u67081\u65e5\u5f00\u59cb\uff0c\u4f1a\u5728\u6240\u6709\u68c0\u67e5\u5b8c\u6210\u540e\u768490\u5929\u5185\u901a\u77e5\u68c0\u67e5\u7ed3\u679c\u7684\u72b6\u6001\uff08OAI, VAI\u6216NAI\uff09\u3002\u8fd9\u5c31\u610f\u5473\u7740\u7559\u7ed9\u5de5\u5382\u56de\u590d483\u7684\u65f6\u95f4\u57fa\u672c\u53ea\u53ef\u80fd\u6709\u4e00\u8f6e\u4e86\u3002\u5728483\u62a5\u544a\u4e2d\u5b58\u5728\u5173\u952e\u7f3a\u9677\u5de5\u5382\u4e00\u5b9a\u8981\u5bf9\u62a5\u544a\u4e2d\u63d0\u5230\u7684\u7f3a\u9677\u90fd\u8fdb\u884c\u6574\u6539\uff0c\u5373\u4f7f\u65f6\u95f4\u4e0a\u6765\u4e0d\u53ca\uff0c\u6700\u597d\u4e5f\u8981\u5217\u51fa\u8be6\u7ec6\u7684\u6574\u6539\u8ba1\u5212\uff0c\u8ba9FDA\u4e00\u6b21\u6027\u6ee1\u610f\uff0c\u6700\u5927\u9650\u5ea6\u675c\u7eddOAI\u7684\u53d1\u751f\u3002\u4f46\u662f\u51fa\u73b0OAI\u7684\u60c5\u51b5\u65f6\uff0cFDA\u548c\u6b27\u76df\u53c8\u5b58\u5728\u533a\u522b\u3002\u6b27\u76df\u5982\u679c\u5728\u68c0\u67e5\u4e2d\u53d1\u73b0\u5173\u952e\u95ee\u9898\uff0c\u5de5\u5382\u7684\u56de\u590d\u53c8\u4e0d\u8ba9\u5b98\u65b9\u6ee1\u610f\u65f6\uff0c\u57fa\u672c\u4e0a\u4f1a\u76f4\u63a5\u53d1\u5e03\u4e0d\u7b26\u5408\u62a5\u544a\u3002\u4f46\u662fFDA\u7684OAI\u7ed3\u679c\uff0c\u5728\u548c\u91c7\u53d6\u5f3a\u5236\u884c\u52a8\u7684\u8b66\u544a\u4fe1\u548c\/\u6216\u8fdb\u53e3\u7981\u4ee4\u4e4b\u95f4\u8fd8\u6709\u4e0d\u5c11\u7684\u7f13\u51b2\u4f59\u5730\u3002\u9664\u4e86\u90a3\u4e9b\u76f4\u63a5\u5f71\u54cd\u75c5\u4eba\u7528\u836f\u5b89\u5168\u7684\u7f3a\u9677\u5916\uff0cFDA\u5728\u4e00\u4e9b\u65f6\u5019\u8fd8\u662f\u4f1a\u7ed9\u6d89\u4e8b\u5de5\u5382\u8fdb\u4e00\u6b65\u6c9f\u901a\u548c\u6574\u6539\u7684\u65f6\u95f4\u7684\u3002\u7b14\u8005\u5728\u53bb\u5e74\u548c\u4eca\u5e74\u5df2\u7ecf\u5206\u522b\u5904\u7406\u8fc72\u6b21OAI\u540e\u7684\u56de\u590d\u548c\u6574\u6539\u5de5\u4f5c\uff0c\u901a\u8fc7\u548cFDA\u7684\u79ef\u6781\u6c9f\u901a\u548c\u52aa\u529b\u6574\u6539\uff0c\u6700\u7ec8\u8fd9\u4e24\u5bb6\u4f01\u4e1a\u90fd\u5f97\u5230\u4e86FDA\u7684\u8ba4\u53ef\uff0c\u6ca1\u6709\u88abFDA\u91c7\u53d6\u4efb\u4f55\u5f3a\u5236\u884c\u52a8\u3002<\/span><\/p>\n


    <\/p>\n

    \u56fe<\/strong>24. FDA<\/strong>\u68c0\u67e5\u65f6\u95f4\u548c\u8b66\u544a\u4fe1\u53d1\u5e03\u65f6\u95f4\u56fe<\/strong><\/span><\/p>\n

    \"\u6b27\u7f8eGMP\u5b98\u65b92018\u5e74\u68c0\u67e5\u6c47\u603b\u5206\u6790\"<\/p>\n


    <\/p>\n

    81\u5c01\u8b66\u544a\u4fe1\u4e2d\u5171\u6709280\u6761\u7f3a\u9677\uff0c\u4e3b\u8981\u5206\u5e03\u8bf7\u89c1\u56fe25\u3002\u5176\u4e2dQA\u7cfb\u7edf\u7f3a\u9677147\u9879\uff0cQC\u7cfb\u7edf\u7f3a\u967782\u9879\uff0c\u5206\u522b\u5360\u603b\u7f3a\u9677\u768453%\u548c29%\u3002\u867d\u7136\u8fd9QA\u548cQC\u4ecd\u7136\u8fd8\u662f\u7f3a\u9677\u6570\u91cf\u6700\u591a\u7684\u4e24\u4e2a\u7cfb\u7edf\uff0c\u4f46\u662f\u5176\u6bd4\u91cd\u4e0e\u76f8\u6bd42017\u5e74\u5ea6\u6709\u5f88\u5927\u7684\u53d8\u5316\uff0cQA\u7cfb\u7edf\u7f3a\u9677\u4ece\u4e0a\u4e00\u5e74\u5ea6\u768432%\u589e\u52a0\u5230\u4e8653%\uff0cQC\u7cfb\u7edf\u7f3a\u9677\u5374\u4ece40%\u964d\u4f4e\u5230\u4e8629%\u3002\u4ece\u7b14\u8005\u5728\u4eca\u5e74\u7ecf\u5386\u7684FDA\u68c0\u67e5\u6765\u770b\uff0cFDA\u68c0\u67e5\u5b98\u5bf9\u4e8eQA\u7cfb\u7edf\uff0c\u7279\u522b\u662f\u6587\u4ef6\u548c\u8bb0\u5f55\u7684\u7ba1\u7406\uff0c\u5de5\u5382\u7684\u8c03\u67e5\u80fd\u529b\uff0cCAPA\u6709\u6548\u6027\u548cOOS\u5904\u7406\u7b49\u65b9\u9762\u7684\u5173\u6ce8\u5ea6\u5728\u589e\u52a0\uff0c\u8fd9\u4e2a\u8d8b\u52bf\u662f\u503c\u5f97\u6211\u4eec\u5927\u5bb6\u5173\u6ce8\u7684\u3002\u5728\u6c47\u603b\u6570\u636e\u65f6\u7b14\u8005\u53d1\u73b0\u4e0d\u540c\u7c7b\u578b\u7684\u5de5\u5382\u4e4b\u95f4\uff0c\u7f3a\u9677\u7684\u7c7b\u522b\u533a\u522b\u8d8a\u6765\u8d8a\u660e\u663e\u3002\u4e00\u65b9\u9762\uff0c\u67d0\u4e9b\u56fd\u5bb6\u548c\u5730\u533a\u7684\u5de5\u5382\uff08\u4f8b\u5982\u65e5\u672c\uff09\uff0c\u4ee5\u53ca\u4e00\u4e9b\u4e2d\u5c0f\u578b\u4f01\u4e1a\u5bf9\u4e8e\u6570\u636e\u5b8c\u6574\u6027\u8fd8\u6ca1\u6709\u6e05\u6670\u7684\u6982\u5ff5\u548c\u5fc5\u8981\u63a7\u5236\uff0c\u6240\u4ee5\u8fd8\u662f\u4f1a\u5728\u8b66\u544a\u4fe1\u4e2d\u770b\u5230\u6570\u91cf\u4e0d\u5c11\u7684\u6570\u636e\u5b8c\u6574\u6027\u76f8\u5173\u7684\u7f3a\u9677\u3002\u57282018\u5e74\u7684\u8b66\u544a\u4fe1\u4e2d\uff0c\u5171\u670914\u5c01\u542b\u6709\u6570\u636e\u5b8c\u6574\u6027\u76f8\u5173\u7684\u7f3a\u9677\uff0c\u536081\u5c01\u8b66\u544a\u4fe1\u768417%\uff0c\u76f8\u6bd42017\u5e74\u768424%\u3002\u867d\u7136\u5448\u73b0\u4e86\u51cf\u5c11\u7684\u8d8b\u52bf\uff0c\u4f46\u662f\u6574\u4f53\u4e0a\u5360\u6bd4\u8fd8\u662f\u63a5\u8fd11\/5\uff0c\u6bd4\u4f8b\u8fd8\u662f\u4e0d\u4f4e\u7684\u3002\u53e6\u4e00\u65b9\u9762\uff0c\u90a3\u4e9b\u6bd4\u8f83\u6210\u719f\u56fd\u5bb6\u548c\u4e2d\u5927\u578b\u4f01\u4e1a\u5df2\u7ecf\u5efa\u7acb\u4e86\u6570\u636e\u5b8c\u6574\u6027\u7684\u57fa\u672c\u7ba1\u7406\u7cfb\u7edf\uff0c\u76f8\u5173\u7684\u63a7\u5236\u63aa\u65bd\u4e5f\u6bd4\u8f83\u5b8c\u5584\u4e86\uff0c\u56e0\u6b64\u5f88\u591a\u7684\u504f\u5dee\u3001OOS\u548c\u5f02\u5e38\u4e8b\u4ef6\u90fd\u5728FDA\u68c0\u67e5\u65f6\u66b4\u9732\u51fa\u6765\u4e86\u3002\u76f8\u5bf9\u4e8e\u66b4\u9732\u51fa\u6765\u7684\u8fd9\u4e9b\u95ee\u9898\uff0c\u5de5\u5382\u7684\u8c03\u67e5\u80fd\u529b\uff0cCAPA\u5236\u5b9a\u7684\u5408\u7406\u6027\u548c\u6709\u6548\u6027\u5374\u6ca1\u6709\u76f8\u5e94\u5730\u53ca\u65f6\u8ddf\u4e0a\uff0c\u6240\u4ee5\u5bfc\u81f4\u4e86\u8b66\u544a\u4fe1\u4e2dQA\u7cfb\u7edf\u7684\u7f3a\u9677\u6bd4\u4f8b\u6025\u5267\u589e\u52a0\u3002\u5176\u4e2d\u8c03\u67e5\u4e0d\u5f7b\u5e95\u7684\u76f8\u5173\u7f3a\u9677\uff0c\u4ece\u4e0a\u4e00\u5e74\u5ea6\u768420%\u589e\u52a0\u5230\u4e8626%\uff1bCAPA\u65e0\u6548\u7684\u76f8\u5173\u7f3a\u9677\u4ece3%\u589e\u957f\u5230\u4e865%\uff0cOOS\u7ba1\u7406\u7684\u76f8\u5173\u7f3a\u9677\u4ece5%\u53d8\u5230\u4e8622%\u3002\u8fd9\u4e5f\u7ed9\u6211\u4eec\u4e2d\u56fd\u4f01\u4e1a\u4e24\u4e2a\u63d0\u9192\uff1a\u7b2c\u4e00\uff0cFDA\u5e76\u6ca1\u6709\u653e\u677e\u5bf9\u4e8e\u6570\u636e\u5b8c\u6574\u6027\u7684\u8981\u6c42\u548c\u76d1\u7ba1\uff0c\u90a3\u4e9b\u8fd8\u62b1\u6709\u4fa5\u5e78\u5fc3\u7406\uff0c\u4e0d\u820d\u5f97\u5728\u76f8\u5173\u786c\u4ef6\u548c\u4eba\u5458\u4e0a\u8fdb\u884c\u6295\u5165\u7684\u6709\u51fa\u53e3\u7f8e\u56fd\u4ea7\u54c1\u7684\u4e2d\u5c0f\u4f01\u4e1a\uff0c\u9700\u8981\u8c28\u614e\u51b3\u7b56\u3002\u5982\u679c\u4e0d\u613f\u653e\u5f03\u7f8e\u56fd\u5e02\u573a\uff0c\u90a3\u8be5\u82b1\u7684\u94b1\uff0c\u8be5\u62db\u7684\u4eba\uff0c\u662f\u8282\u7701\u4e0d\u4e86\u7684\u3002\u7b2c\u4e8c\uff0c\u5df2\u7ecf\u7b26\u5408\u6570\u636e\u5b8c\u6574\u6027\u8981\u6c42\u7684\u4f01\u4e1a\uff0c\u4e5f\u4e0d\u8981\u76f2\u76ee\u4e50\u89c2\uff0c\u89c9\u5f97\u81ea\u5df1\u53ef\u4ee5\u4e00\u52b3\u6c38\u9038\u4e86\u3002\u7b26\u5408\u6570\u636e\u5b8c\u6574\u6027\u7684\u7cfb\u7edf\u7684\u540e\u7eed\u8fd0\u884c\u548c\u7ef4\u62a4\uff0c\u4ea7\u751f\u7684\u6570\u636e\u7684\u7ba1\u7406\uff0c\u51fa\u73b0\u5f02\u5e38\u6570\u636e\u7684\u8c03\u67e5\u548cCAPA\uff0c\u662f\u9700\u8981\u8fd9\u4e9b\u4f01\u4e1a\u6301\u7eed\u7684\u6295\u5165\u548c\u5173\u6ce8\u7684\u3002\u4e0e\u6b64\u7c7b\u95ee\u9898\u76f8\u5173\u7684\u7f3a\u9677\uff0c\u5df2\u7ecf\u591a\u6b21\u5728\u6211\u4eec\u6d77\u87ba\u7814\u4e60\u793e\u89e3\u8bfb\u7684483\u4e2d\u51fa\u73b0\u4e86\uff0c\u5982\u6709\u5174\u8da3\u7684\u8bfb\u8005\u53ef\u4ee5\u7ffb\u770b\u76f8\u5173483\u89e3\u8bfb\u3002<\/span><\/p>\n


    <\/p>\n

    \u56fe<\/strong>25. FDA <\/span><\/strong>\u8b66\u544a\u4fe1\u4e2d\u8d28\u91cf\u4f53\u7cfb\u7f3a\u9677\u9879\u76ee\u5206\u5e03\u56fe<\/strong><\/span><\/p>\n

    \n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

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