{"id":118991,"date":"2026-10-28T16:09:21","date_gmt":"2026-10-28T08:09:21","guid":{"rendered":"https:\/\/www.wsisp.com\/helps\/118991.html"},"modified":"2026-10-28T16:09:21","modified_gmt":"2026-10-28T08:09:21","slug":"%e9%aa%8c%e8%af%81%e3%80%81%e7%a1%ae%e8%ae%a4%e3%80%81%e6%a0%a1%e5%87%86%ef%bc%9agmp-%e4%b8%89%e4%b8%aa%e8%af%8d%e6%b7%b7%e7%9d%80%e7%94%a8%ef%bc%8c%e6%a3%80%e6%9f%a5%e5%ae%98%e4%b8%80%e6%ac%a1","status":"publish","type":"post","link":"https:\/\/www.wsisp.com\/helps\/118991.html","title":{"rendered":"\u9a8c\u8bc1\u3001\u786e\u8ba4\u3001\u6821\u51c6\uff1aGMP \u4e09\u4e2a\u8bcd\u6df7\u7740\u7528\uff0c\u68c0\u67e5\u5b98\u4e00\u6b21\u5f00\u4e09\u6761\u7f3a\u9677"},"content":{"rendered":"

\"\u5bf9\u8c61\u5bf9\u4e86\uff0c\u52a8\u8bcd\u624d\u5bf9\"<\/p>\n

2016 \u5e74\u5728\u7b2c\u4e09\u65b9\u68c0\u6d4b\u673a\u6784\u7ba1\u5b9e\u9a8c\u5ba4\u7cfb\u7edf，QA \u62ff\u7740\u4e00\u4efd\u521a\u5f52\u6863\u7684\u6587\u4ef6\u56de\u5934\u95ee\u6211\u4e00\u53e5："\u8fd9\u4efd\u53eb\u300a\u79bb\u5fc3\u673a\u9a8c\u8bc1\u62a5\u544a\u300b，\u91cc\u9762\u53ea\u6709\u5b89\u88c5\u786e\u8ba4\u548c\u8fd0\u884c\u786e\u8ba4，\u6027\u80fd\u786e\u8ba4\u90a3\u8282\u5199'\u89c1\u4f9b\u5e94\u5546\u51fa\u5382\u62a5\u544a'，\u8fd9\u7b97\u505a\u5b8c\u4e86\u5417？"<\/p>\n

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EU GMP Annex 15\u300a\u786e\u8ba4\u4e0e\u9a8c\u8bc1\u300b（2015-10-01 \u751f\u6548）\u8bf4\u5f97\u66f4\u76f4\u767d：\u786e\u8ba4\u662f\u9a8c\u8bc1\u7684\u4e00\u90e8\u5206，\u5355\u72ec\u7684\u786e\u8ba4\u6b65\u9aa4\u4e0d\u6784\u6210\u5de5\u827a\u9a8c\u8bc1\u3002\u6821\u51c6\u4e0d\u5728\u8fd9\u6761\u7ebf\u4e0a，GMP \u7b2c\u4e94\u7ae0\u8981\u6c42\u6309\u6821\u51c6\u8ba1\u5212\u5b9a\u671f\u5bf9\u8861\u5668\u3001\u91cf\u5177\u3001\u4eea\u8868\u548c\u63a7\u5236\u8bbe\u5907\u6821\u51c6\u5e76\u7559\u8bb0\u5f55\u3002<\/p>\n

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\nDQ \u5bf9 URS（\u7528\u6237\u9700\u6c42\u8bf4\u660e）\u9010\u6761\u5e94\u7b54，IQ \u6838\u5230\u8d27\u3001\u5b89\u88c5\u4e0e\u516c\u7528\u5de5\u7a0b\u63a5\u53e3，OQ \u7528\u6311\u6218\u6027\u6761\u4ef6\u6d4b\u4e0a\u4e0b\u9650，PQ \u7528\u5b9e\u9645\u6837\u54c1\u6216\u5b9e\u9645\u5de5\u51b5\u8fde\u8dd1\u3002
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\n\u4e3a\u4ec0\u4e48：\u529f\u80fd\u6d4b\u901a\u53ea\u8bf4\u660e"\u80fd\u7528"\u3002Annex 11 \u7b2c 9 \u8282\u76ef\u7684\u662f"\u6539\u4e86\u4ec0\u4e48\u7559\u4e0d\u7559\u75d5"\u3002<\/p>\n

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\u9a8c\u8bc1<\/td>\nValidation<\/td>\n\u5de5\u827a\u3001\u5206\u6790\u65b9\u6cd5\u3001\u64cd\u4f5c\u89c4\u7a0b\u3001\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf<\/td>\n\u9a8c\u8bc1\u65b9\u6848\u4e0e\u62a5\u544a（VP\/VR）\u3001\u65b9\u6cd5\u9a8c\u8bc1\u62a5\u544a<\/td>\n\u8bbe\u5907\u53ea\u505a IQ\/OQ \u4e5f\u53eb"\u9a8c\u8bc1\u62a5\u544a"<\/td>\n<\/tr>\n
\u786e\u8ba4<\/td>\nQualification<\/td>\n\u5382\u623f\u3001\u8bbe\u65bd\u3001\u8bbe\u5907\u3001\u516c\u7528\u7cfb\u7edf<\/td>\nDQ\u3001IQ\u3001OQ\u3001PQ \u56db\u4efd\u65b9\u6848\u4e0e\u62a5\u544a<\/td>\n\u53ea\u6709 IQ \u5c31\u51fa"\u9a8c\u8bc1\u603b\u7ed3"<\/td>\n<\/tr>\n
\u6821\u51c6<\/td>\nCalibration<\/td>\n\u6d4b\u91cf\u8bbe\u5907\u7684\u793a\u503c\u4e0e\u8ba1\u91cf\u6807\u51c6\u91cf\u503c\u4e4b\u5dee<\/td>\n\u6821\u51c6\u8bc1\u4e66（\u793a\u503c\u8bef\u5dee\u3001\u4e0d\u786e\u5b9a\u5ea6\u3001\u4fee\u6b63\u503c）<\/td>\n\u62ff\u6821\u51c6\u8bc1\u4e66\u5f53\u7cfb\u7edf\u5408\u89c4\u8bc1\u636e<\/td>\n<\/tr>\n
\u68c0\u5b9a<\/td>\nVerification（\u8ba1\u91cf\u5668\u5177）<\/td>\n\u5217\u5165\u5f3a\u5236\u68c0\u5b9a\u76ee\u5f55\u7684\u8ba1\u91cf\u5668\u5177<\/td>\n\u68c0\u5b9a\u8bc1\u4e66（\u7ed9\u5408\u683c\u4e0e\u5426\u7684\u7ed3\u8bba）<\/td>\n\u628a"\u68c0\u5b9a"\u5199\u6210"\u6821\u51c6"，\u6216\u53cd\u8fc7\u6765<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u547d\u540d\u66ff\u6362\u6e05\u5355，\u5de6\u8fb9\u662f\u5e38\u5199\u7684，\u53f3\u8fb9\u662f\u8be5\u5199\u7684：<\/p>\n

  • \u300aXX \u8bbe\u5907\u9a8c\u8bc1\u65b9\u6848\u300b\u2192\u300aXX \u8bbe\u5907 DQ\/IQ\/OQ\/PQ \u65b9\u6848\u300b，\u56db\u4efd\u5206\u5f00\u7f16<\/li>\n
  • \u300aXX \u7cfb\u7edf\u786e\u8ba4\u62a5\u544a\u300b\u2192\u300aXX \u7cfb\u7edf\u9a8c\u8bc1\u62a5\u544a（CSV）\u300b<\/li>\n
  • \u300a\u4eea\u5668\u6821\u9a8c\u8bb0\u5f55\u300b\u300a\u65b9\u6cd5\u786e\u8ba4\u62a5\u544a\u300b（\u5168\u9a8c\u8bc1\u573a\u666f）\u2192\u300a\u4eea\u5668\u6821\u51c6\u8bb0\u5f55\u300b\u300a\u65b9\u6cd5\u9a8c\u8bc1\u62a5\u544a\u300b<\/li>\n
  • \u300a\u9a8c\u8bc1\u603b\u7ed3\u300b\u2192\u300a\u9a8c\u8bc1\u603b\u7ed3\u62a5\u544a VSR\u300b，\u7ed3\u8bba\u9875\u5199\u660e\u56db\u6bb5\u72b6\u6001\u4e0e\u8c41\u514d\u7406\u7531<\/li>\n

    \u626b\u5b8c\u4f60\u4f1a\u53d1\u73b0，\u8981\u6539\u540d\u7684\u6587\u4ef6\u91cc\u6709\u4e00\u534a\u4e0d\u53ea\u662f\u540d\u5b57\u9519\u4e86，\u662f\u6bb5\u6570\u672c\u6765\u5c31\u7f3a\u3002<\/p>\n

    \u68c0\u67e5\u5b98\u4f1a\u600e\u4e48\u95ee<\/h3>\n

    "\u8fd9\u4efd\u53eb\u9a8c\u8bc1\u62a5\u544a，\u4e3a\u4ec0\u4e48\u53ea\u6709 IQ \u548c OQ？"
    \n\u7b54：\u8fd9\u53f0\u662f\u8bbe\u5907，\u89c4\u8303\u91cc\u5bf9\u5e94\u786e\u8ba4；PQ \u56e0\u8be5\u8bbe\u5907\u53ea\u7528\u4e8e\u975e GxP（\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u53ca\u76f8\u5173\u8d28\u91cf\u89c4\u8303\u7684\u603b\u79f0）\u7684\u8f85\u52a9\u5de5\u5e8f，\u7ecf\u98ce\u9669\u8bc4\u4f30\u8c41\u514d，\u6279\u51c6\u9875\u5728\u7b2c\u51e0\u9875\u3002\u522b\u7b54"\u4f9b\u5e94\u5546\u505a\u8fc7\u4e86"\u3002<\/p>\n

    "\u6821\u51c6\u8bc1\u4e66\u4e0a\u5199\u7740\u5408\u683c，\u4e3a\u4ec0\u4e48\u8fd8\u8981\u505a OQ？"
    \n\u7b54：\u6821\u51c6\u53ea\u8bc1\u660e\u793a\u503c\u8bef\u5dee\u5728\u5141\u5dee\u5185，OQ \u8bc1\u660e\u529f\u80fd\u4e0e\u6743\u9650\u7b26\u5408 URS，\u4e24\u8005\u8bc1\u660e\u5bf9\u8c61\u4e0d\u540c，\u4e0d\u80fd\u4e92\u66ff\u3002<\/p>\n

    "\u4f60\u4eec SOP \u91cc'\u6821\u9a8c'\u6307\u7684\u662f\u6821\u51c6\u8fd8\u662f\u786e\u8ba4？"
    \n\u7b54：\u6307\u6821\u51c6，\u5168\u6587\u5df2\u7edf\u4e00，\u672f\u8bed\u8868\u5728\u7b2c\u51e0\u8282\u3002\u7b54\u4e0d\u4e0a\u6765\u5c31\u522b\u8fa9\u89e3，\u56de\u53bb\u7edf\u4e00\u672f\u8bed\u6bd4\u89e3\u91ca\u5feb\u3002<\/p>\n

    \u4e00\u53e5\u603b\u7ed3<\/h3>\n

    \u786e\u8ba4\u7ba1\u8bbe\u5907，\u9a8c\u8bc1\u7ba1\u8fc7\u7a0b，\u6821\u51c6\u7ba1\u793a\u503c；\u52a8\u8bcd\u5199\u9519，\u68c0\u67e5\u5b98\u6309\u4e09\u4e2a\u7f3a\u9677\u5f00\u3002<\/p>\n

    \u4e0b\u4e00\u7bc7：\u7b2c 07 \u7bc7\u300a\u8c01\u6765\u505a CSV：QA\u3001IT\u3001\u4e1a\u52a1\u3001\u4f9b\u5e94\u5546\u7684\u8fb9\u754c\u300b\u2014\u2014RACI \u8868\u9519\u4e00\u683c，\u9a8c\u8bc1\u671f\u5c31\u6709\u4e24\u62e8\u4eba\u540c\u65f6\u4ee5\u4e3a\u5bf9\u65b9\u5728\u7b7e\u5b57\u3002<\/p>\n

    \u6cd5\u89c4\u4f9d\u636e<\/h3>\n
  • \u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303（2010 \u5e74\u4fee\u8ba2）\u300b，\u536b\u751f\u90e8\u4ee4\u7b2c 79 \u53f7，2011-03-01 \u65bd\u884c\u3002<\/li>\n
  • \u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303（2010 \u5e74\u4fee\u8ba2）\u300b\u9644\u5f55\u300a\u786e\u8ba4\u4e0e\u9a8c\u8bc1\u300b，\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40，2015 \u5e74\u53d1\u5e03，2015-12-01 \u65bd\u884c\u3002<\/li>\n
  • EU GMP Annex 15: Qualification and Validation，European Commission，2015-10-01 \u751f\u6548\u3002<\/li>\n
  • EU GMP Annex 11: Computerised Systems，European Commission，2011-06-30 \u751f\u6548\u3002<\/li>\n
  • \u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u8ba1\u91cf\u6cd5\u300b，1985 \u5e74\u901a\u8fc7，2018 \u5e74\u4fee\u6b63\u3002<\/li>\n
  • ICH Q2(R2): Validation of Analytical Procedures，ICH，2023 \u5e74\u901a\u8fc7\u3002<\/li>\n

    \u5173\u4e8e\u6211<\/h3>\n

    \u5728\u5b9e\u9a8c\u5ba4\u4e00\u7ebf\u5f85\u4e86 13 \u5e74（9 \u5e74\u5236\u836f + 4 \u5e74\u7b2c\u4e09\u65b9\u68c0\u6d4b），\u505a\u7684\u4e00\u76f4\u662f\u5b9e\u9a8c\u5ba4\u4fe1\u606f\u5316\u3002\u505a\u8fc7\u67d0\u5546\u4e1a LIMS \u4ea7\u54c1\u7684\u7532\u65b9 PM\u2014\u2014\u4e00\u671f\u3001\u4e8c\u671f\u4e24\u8f6e\u4e0a\u7ebf\u90fd\u7531\u6211\u4e3b\u5bfc（\u62db\u6807\u5230 3Q \u9a8c\u8bc1\u5230\u9a8c\u6536\u5168\u6d41\u7a0b）；\u4e5f\u5728\u90a3\u5957\u7cfb\u7edf\u4e0a\u81ea\u5df1\u505a\u8fc7\u4e8c\u6b21\u5f00\u53d1\u2014\u2014\u628a\u7eb8\u8d28\u7684\u8d26\u53f7\u7533\u8bf7\u6d41\u7a0b\u642c\u5230\u7ebf\u4e0a\u8dd1；\u5728\u90a3\u4e4b\u524d\u8fd8\u6709 6 \u5e74\u591a CS \u67b6\u6784 LIMS \u7684\u4f7f\u7528\u4e0e\u8fd0\u7ef4\u7ecf\u9a8c（\u5176\u4e2d\u4e00\u6bb5\u7ecf\u8fdc\u7a0b\u684c\u9762\u63a5\u5165）\u3002\u73b0\u5728\u4e13\u505a\u5b9e\u9a8c\u5ba4\u91cc\u90a3\u4e9b\u91cd\u590d\u52b3\u52a8：\u62a5\u8868\u81ea\u52a8\u751f\u6210\u3001\u4eea\u5668\u6570\u636e\u5bf9\u63a5\u3001\u5408\u89c4\u6587\u6863\u6279\u91cf\u5904\u7406\u3002<\/p>\n

    \u672c\u79d1\u7269\u7406\u5316\u5b66\u3001\u7855\u58eb\u8ba1\u7b97\u673a\u5316\u5b66，\u65e2\u542c\u5f97\u61c2 QA \u8bf4\u7684\u53d8\u66f4\u63a7\u5236，\u4e5f\u770b\u5f97\u61c2\u4eea\u5668\u5bfc\u51fa\u7684\u539f\u59cb\u6570\u636e\u957f\u4ec0\u4e48\u6837\u3002SOP\u3001\u504f\u5dee\u3001OOS\u3001\u6837\u672c\u6d41\u8f6c\u8fd9\u4e9b\u8bcd，\u4e0d\u7528\u4f60\u89e3\u91ca\u3002<\/p>\n

    \u73b0\u5728\u4e3b\u8981\u505a\u8fd9\u51e0\u7c7b：
    \n– \u68c0\u9a8c\u62a5\u544a\u4e0e\u53f0\u8d26\u6279\u91cf\u751f\u6210：\u6a21\u677f\u4e0d\u52a8，\u6570\u636e\u81ea\u52a8\u586b，\u683c\u5f0f\u4e00\u6b65\u4e0d\u9519
    \n– \u4eea\u5668\u6570\u636e\u5bf9\u63a5：\u8272\u8c31\u3001\u5149\u8c31\u3001\u9176\u6807\u4eea\u5bfc\u51fa\u7684\u539f\u59cb\u6587\u4ef6，\u89e3\u6790\u3001\u6e05\u6d17\u3001\u5165\u5e93\u3001\u8f6c\u6210\u62a5\u8868
    \n– \u5408\u89c4\u6587\u6863\u81ea\u52a8\u5316：SOP\u3001\u9a8c\u8bc1\u65b9\u6848\u3001\u6279\u8bb0\u5f55\u8fd9\u7c7b\u91cd\u590d\u6587\u6863\u7684\u6279\u91cf\u751f\u6210\u4e0e\u6838\u5bf9
    \n– \u6570\u636e\u5b8c\u6574\u6027\u6838\u67e5：\u6309 ALCOA+ \u9010\u6761\u6838\u5bf9\u539f\u59cb\u6570\u636e\u4e0e\u8bb0\u5f55\u662f\u5426\u5bf9\u5f97\u4e0a<\/p>\n

    \u624b\u91cc\u6709\u8fd9\u7c7b\u6d3b\u513f\u5361\u7740，\u6216\u8005\u53ea\u662f\u60f3\u95ee\u95ee\u80fd\u4e0d\u80fd\u81ea\u52a8\u5316，\u90fd\u6b22\u8fce\u8bc4\u8bba\u533a\u804a，\u5148\u628a\u95ee\u9898\u8bf4\u6e05\u695a\u518d\u8c08\u600e\u4e48\u505a\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

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