{"id":105225,"date":"2019-03-17T00:00:50","date_gmt":"2019-05-17T09:02:37","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/105225\/"},"modified":"2019-05-17T17:02:40","modified_gmt":"2019-05-17T09:02:40","slug":"30863b262f","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/105225\/","title":{"rendered":"\u8d28\u91cf\u4eba\u5fc5\u8bfb|Qualification \u548c Validation \u7684\u533a\u522b"},"content":{"rendered":"
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\u6458\u8981<\/section>\n<\/section>\n<\/section>\n

Qualification\u548cValidation\u662f\u6709\u533a\u522b\u7684\u3002 Qualification\u603b\u662f\u5bf9\u4e8e\u5177\u4f53\u7684\u5b9e\u7269\u800c\u8a00\uff0c\u901a\u5e38\u7528\u4e8e\u5382\u623f\u3001\u8bbe\u5907\u548c\u8bbe\u65bd\u3002\u8fd9\u4e9b\u76ee\u6807\u7269\u662f\u770b\u5f97\u89c1\uff0c\u6478\u5f97\u7740\u7684\u3002\u8fd9\u4e9b\u76ee\u6807\u7269\u90fd\u4f1a\u6709\u5404\u81ea\u7684\u6807\u51c6\uff08URS\u6216\u6027\u80fd\u6307\u6807\uff09\uff0cQualification\u5de5\u4f5c\u5f80\u5f80\u90fd\u662f\u901a\u8fc7\u4e00\u7cfb\u5217\u7684Verification\u6d3b\u52a8\uff08\u6d4b\u8bd5\u3001\u8bd5\u9a8c\u3001\u6838\u5b9e\u7b49\u7b49\uff09\u6765\u68c0\u67e5\u76ee\u6807\u7269\u662f\u5426\u8fbe\u5230\u4e86\u8fd9\u4e9b\u8981\u6c42\u3002\u56e0\u6b64\u4eba\u4eec\u603b\u662f\u8bf4”\u8bbe\u5907\u786e\u8ba4”\uff0c\u800c\u4e0d\u8bf4”\u8bbe\u5907\u9a8c\u8bc1”\u3002Qualification\u4e0d\u5f3a\u8c03\u91cd\u590d\uff0c\u53ea\u8981\u6d4b\u8bd5\u7ed3\u679c\u7b26\u5408\u4e86\u9884\u671f\u6807\u51c6\uff0c\u5c31\u7b97\u662f\u901a\u8fc7\u4e86\u3002\u8fd9\u4e9b\u5177\u4f53\u5b9e\u7269\u7684\u7279\u70b9\u662f\u4e00\u65e6\u901a\u8fc7\u4e86\u9884\u671f\u6807\u51c6\u5c31\u4f1a\u6309\u7167\u8be5\u6807\u51c6\u8fd0\u884c\u3002 Qualification\u662f\u9a8c\u8bc1\u7684\u4e00\u4e2a\u90e8\u5206\uff0c\u4f46\u5176\u672c\u8eab\u4e0d\u80fd\u4ee3\u66ff\u5de5\u827a\u9a8c\u8bc1\u3002<\/span><\/h3>\n


<\/h3>\n

\u800c\u9a8c\u8bc1\uff08Validation\uff09\u7684\u76ee\u6807\u4f53\u603b\u662f\u5de5\u827a\u3001\u65b9\u6cd5\u6216\u89c4\u7a0b\uff0c \u5b83\u4eec\u4e0d\u662f\u5177\u4f53\u7684\u76ee\u6807\u7269\uff0c\u4eba\u4eec\u65e0\u6cd5\u89e6\u6478\u4e00\u4e2a\u5de5\u827a\uff0c\u800c\u4e14\u5b83\u4eec\u7684\u7ed3\u679c\u901a\u5e38\u4e0d\u80fd\u88abverify \u3002\u56e0\u6b64\u4eba\u4eec\u5e38\u8bf4”\u5de5\u827a\u9a8c\u8bc1”\u3001”\u65b9\u6cd5\u9a8c\u8bc1”\u3001”\u6e05\u6d01\u9a8c\u8bc1”\u7b49\u7b49\u3002  \u5de5\u827a\uff0c\u65b9\u6cd5\u548c\u89c4\u7a0b\u4e00\u5b9a\u662f\u901a\u8fc7\u5177\u4f53\u7684\u4eea\u5668\u3001\u8bbe\u5907\u548c\u7cfb\u7edf\u6765\u5b9e\u73b0\u7684\uff0c\u56e0\u6b64\u5bf9\u53c2\u4e0e\u5230\u5de5\u827a\uff0c\u65b9\u6cd5\u548c\u89c4\u7a0b\u4e2d\u7684\u8bbe\u5907\u3001\u8bbe\u65bd\u548c\u7cfb\u7edf\u7684Qualification\u5c31\u6210\u4e3aValidation\u7684\u524d\u63d0\u3002\u53e6\u5916\u5f88\u91cd\u8981\u7684\u4e00\u70b9\u662fValidation\u4e00\u5b9a\u8981\u5f3a\u8c03\u91cd\u590d\u6216\u8005\u59cb\u7ec8\u4e00\u8d2f\u5730\u6709\u6548\u3002<\/span><\/h3>\n


<\/h3>\n

\u4f46\u662fQualification\u548cValidation\u7684\u754c\u9650\u8d8a\u6765\u8d8a\u6a21\u7cca\u4e86\uff0c\u5c24\u5176\u662f\u7f8e\u56fdFDA\u63d0\u51fa\u4e86”Process Qualification\u5de5\u827a\u786e\u8ba4”\u7684\u6982\u5ff5\u4ee5\u540e\uff0c\u4f7f\u5f97\u591a\u5e74 “\u8bbe\u5907\u786e\u8ba4”\u3001”\u5de5\u827a\u9a8c\u8bc1”\u7684\u8bf4\u6cd5\u88ab\u63a8\u7ffb\u4e86\u3002  \u4f46\u7b14\u8005\u8ba4\u4e3aFDA\u6240\u8c13\u7684”Process Qualification”\u5176\u5b9e\u5c31\u662f\u5de5\u827a\u7684\u521d\u59cb\u9a8c\u8bc1\u7f62\u4e86\u3002<\/span><\/h3>\n
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\u5f15\u8a00<\/section>\n<\/section>\n<\/section>\n

\u5236\u836f\u90fd\u79bb\u4e0d\u5f00GMP\uff0c\u800cGMP\u603b\u662f\u5c11\u4e0d\u4e86\u786e\u8ba4\u548c\u9a8c\u8bc1\u3002\u90a3\u4e48\u786e\u8ba4\u548c\u9a8c\u8bc1\u5230\u5e95\u6709\u4ec0\u4e48\u533a\u522b\uff1f\u66fe\u7ecf\u591a\u6b21\u6709\u540c\u4e8b\u95ee\u6211\u8fd9\u4e2a\u95ee\u9898\u3002\u8981\u641e\u6e05\u695a\u8fd9\u4e2a\u95ee\u9898\uff0c\u5c31\u5fc5\u987b\u8981\u7406\u89e3\u4e09\u4e2a\u8bcdValidation\uff0cQualification\u548cVerification\u7684\u82f1\u8bed\u539f\u610f\u3002\u4e0d\u8fc7\u5728\u8bb2\u89e3\u8fd9\u4e09\u4e2a\u8bcd\u4e4b\u524d\uff0c\u8bf7\u60f3\u8c61\u4e00\u4e0b\u5982\u679c\u4e00\u4e2a\u6b63\u5728\u5b66\u4e2d\u6587\u7684\u5916\u56fd\u670b\u53cb\u95ee\u4f60\uff1a\u201c\u8857\u201d\u3001\u201c\u9053\u201d\u548c\u201c\u8def\u201d\u6709\u4ec0\u4e48\u533a\u522b\uff1f\u60a8\u5982\u4f55\u56de\u7b54\u5462\uff1f\u6211\u4eec\u7406\u89e3\u201cVerification\u201d\u3001\u201cQualification\u201d\u548c\u201cValidation\u201d\u53ef\u80fd\u5c31\u50cf\u5916\u56fd\u4eba\u7406\u89e3\u201c\u8857\u201d,\u201c\u9053\u201d\u548c\u201c\u8def\u201d\u7684\u533a\u522b\uff0c\u53ef\u80fd\u6c38\u8fdc\u8fbe\u4e0d\u5230\u90a3\u79cd\u201c\u53ea\u53ef\u610f\u4f1a\u4e0d\u53ef\u8a00\u4f20\u201d\u7684\u5883\u754c\u3002<\/span><\/h3>\n
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Verification<\/section>\n<\/section>\n<\/section>\n

\u8fd9\u4e2a\u8bcd\u6765\u81ea\u4e8e\u82f1\u8bed\u7684Verify\u3002\u610f\u601d\u662f \u201cto find out a fact or statements\u2026etc. is true\u53bb\u6838\u5b9e\u4e00\u4e2a\u4e8b\u5b9e\u6216\u8bf4\u6cd5\u662f\u771f\u5b9e\u7684\u201d\uff0c \u4e5f\u5c31\u662f\u67e5\u9a8c\uff08check\uff09\u7684\u610f\u601d\u3002\u5176\u9690\u542b\u7684\u610f\u4e49\u662f\u201c\u5df2\u7ecf\u6709\u67d0\u4e2a\u4e8b\u5b9e\u6216\u8bf4\u6cd5\u5b58\u5728\u201d\uff0c\u800c\u8fd9\u4e2a\u52a8\u4f5c\u5c31\u662f\u627e\u51fa\u8fd9\u4e2a\u4e8b\u5b9e\u6216\u8bf4\u6cd5\u662f\u771f\u5b9e\u7684\u3002\u4e3e\u4e2a\u4f8b\u5b50\uff0c\u6211\u4eec\u53ef\u4ee5\u8bf4\uff1a\u201c\u8bf7verify\u5f20\u4e09\u662f\u4e0d\u662f\u4e00\u4e2aGMP\u5ba1\u6838\u5458\u201d\u3002\u8fd9\u4e2a\u52a8\u4f5c\u7684\u9690\u542b\u524d\u63d0\u662f\u5df2\u7ecf\u6709 \u201c\u5f20\u4e09\u662fGMP\u5ba1\u6838\u5458\u201d\u7684\u8bf4\u6cd5\u5b58\u5728\u4e86\u3002\u5236\u836f\u754c\u5bf9\u8fd9\u4e2a\u8bcd\u7684\u7ffb\u8bd1\u91cd\u8981\u6027\u5c1a\u6ca1\u6709\u5171\u540c\u8ba4\u53ef\u3002\u76ee\u524d\u6700\u8d34\u5207\u7684\u7ffb\u8bd1\u662f\u201c\u786e\u8bc1\u201d\u3002<\/span><\/h3>\n
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Qualification<\/section>\n<\/section>\n<\/section>\n

\u8fd9\u4e2a\u8bcd\u5236\u836f\u754c\u7684\u670b\u53cb\u90fd\u975e\u5e38\u719f\u8bc6\uff0c\u6765\u81ea\u4e8eQualify\uff0c\u4e00\u76f4\u88ab\u516c\u8ba4\u7ffb\u8bd1\u4e3a”\u786e\u8ba4”\u3002\u53ef\u662f\u4f30\u8ba1\u5f88\u5c11\u6709\u4eba\u771f\u6b63\u7406\u89e3Qualify\u662f\u4ec0\u4e48\u610f\u601d\u3002\u5176\u539f\u610f\u662f\u6307”to pass an exam or meet the standards of something”, \u5373”\u8fbe\u5230\u4e86\u4e00\u5b9a\u7684\u6807\u51c6\uff0c\u4ece\u800c\u80fd\u591f\u505a\u67d0\u79cd\u4e8b\u60c5”\u3002\u8bbe\u5907\u7684Qualification\u662f\u5176\u539f\u610f\u7684\u5ef6\u4f38\uff0c\u5373\u67d0\u4e2a\u8bbe\u5907\u8fbe\u5230\u4e86\u4e00\u5b9a\u7684\u6807\u51c6\uff0c\u53ef\u4ee5\u88ab\u7528\u6765\u505a\u67d0\u4e2a\u9884\u5b9a\u7684\u751f\u4ea7\u6b65\u9aa4\u3002Qualification\u7684\u8fc7\u7a0b\u4e00\u5b9a\u8981\u6709”\u9884\u5b9a\u7684\u6807\u51c6”\u3002\u6bd4\u5982\uff1a\u5f20\u4e09\u662f\u5927\u5b66\u6bd5\u4e1a\uff0c\u7ecf\u8fc7\u4e86GMP\u5ba1\u8ba1\u76f8\u5173\u7684\u57f9\u8bad\uff0c\u53c2\u52a0\u8fc7\u591a\u6b21GMP\u5ba1\u8ba1\uff0c\u5728\u5236\u836f\u4f01\u4e1a\u505a\u4e86\u5341\u591a\u5e74\u7b49\u7b49\u3002\u5047\u8bbe\u8fd9\u4e9b\u662f\u4e00\u4e2aGMP\u5ba1\u6838\u5458\u6240\u5fc5\u5907\u7684\u6807\u51c6\uff0c\u5f53\u5f20\u4e09\u8fbe\u5230\u4e86\u8fd9\u4e9b\u6807\u51c6\u65f6\uff0c\u6211\u4eec\u5c31\u8ba4\u4e3a”\u5f20\u4e09\u88ab\u2018qualified\u2019\u4e3a\u4e00\u4e2a\u5408\u683cGMP\u5ba1\u6838\u5458”\u3002\u8fd9\u4e9b\u6536\u96c6\u8bc1\u636e\u6765\u8bc1\u660e\u5f20\u4e09\u8fbe\u5230\u4e86\u8fd9\u4e9b\u6807\u51c6\uff0c\u5305\u62ec\u5982\u679c\u5f20\u4e09\u6ca1\u6709\u5b8c\u6210\u76f8\u5e94\u7684\u57f9\u8bad\uff0c\u4fc3\u4f7f\u5f20\u4e09\u5b8c\u6210\u8fd9\u4e9b\u57f9\u8bad\u7b49\u6d3b\u52a8\u6070\u6070\u5c31\u662fQualification\u7684\u5de5\u4f5c\u3002 \u8bbe\u5907\u7684Qualification\u4e5f\u662f\u540c\u6837\u7684\u9053\u7406\u3002\u8bbe\u5907\u7684URS\u548c\u6027\u80fd\u6307\u6807\uff08functional  specifications\uff09\u51b3\u5b9a\u4e86\u8bbe\u5907\u7684\u6807\u51c6\uff0c\u786e\u8ba4\u5c31\u662f\u901a\u8fc7\u5b9e\u9645\u64cd\u4f5c\u3001\u6d4b\u8bd5\u6216\u8bd5\u9a8c\uff0c\u6765\u6536\u96c6\u8bc1\u636e\uff0c\u8bc1\u660e\u8be5\u8bbe\u5907\u5df2\u7ecf\u8fbe\u5230\u4e86\u8fd9\u4e9b\u6807\u51c6\u3002\u6bd4\u5982\u4e00\u4e2a\u4f20\u611f\u5668\u7684\u6027\u80fd\u662f\uff1a”\u8bfb\u53d6\u6807\u7b7e\u4e0a\u7684\u6761\u7801\u5e76\u5224\u65ad\u6761\u7801\u662f\u5426\u6b63\u786e\uff0c\u5982\u679c\u4e0d\u53ef\u8bfb\u6216\u4e0d\u6b63\u786e\uff0c\u5c06\u8be5\u6807\u7b7e\u5254\u9664”\u3002\u5bf9\u5176\u6240\u505a\u7684Qualification\u5e94\u8be5\u662f\u4eba\u4e3a\u7834\u574f\u6807\u7b7e\u4e0a\u7684\u6761\u7801\u6216\u7528\u53e6\u4e00\u4e2a\u6761\u7801\u4ee3\u66ff\uff0c\u89c2\u5bdf\u6807\u7b7e\u662f\u5426\u88ab\u5254\u9664\uff0c \u5e76\u8bb0\u5f55\u7ed3\u679c\u3002<\/span><\/h3>\n


<\/h3>\n

\u628aQualification\u8fd9\u4e2a\u8bcd\u7684\u7ffb\u8bd1\u4e3a”\u786e\u8ba4”\u5e76\u4e0d\u8d34\u5207\u3002\u540c\u6837\u7528\u4e0a\u9762\u7684\u4f8b\u5b50\uff0c\u6211\u4eec\u53ef\u4ee5\u8bf4\uff1a”\u8bf7\u628a\u5f20\u4e09qualify\u4e3a\u4e00\u4e2aGMP\u5ba1\u6838\u5458”\uff0c\u800c\u4e0d\u53ef\u4ee5\u8bf4\uff1a”\u8bf7\u53bbQualify\u5f20\u4e09\u662f\u4e0d\u662f\u5408\u683c\u7684GMP\u5ba1\u6838\u5458”\u3002\u53ef\u662f\u5982\u679c\u6211\u4eec\u628aQualify\u7684\u7ffb\u8bd1”\u786e\u8ba4”\u5e26\u5165\u4ee5\u4e0a\u7684\u53e5\u5b50\uff0c\u5c31\u6210\u4e3a\uff1a”\u8bf7\u628a\u5f20\u4e09\u2018\u786e\u8ba4\u2019\u4e3a\u4e00\u4e2aGMP\u5ba1\u6838\u5458”\u548c”\u8bf7\u53bb\u2018\u786e\u8ba4\u2019\u5f20\u4e09\u662f\u4e0d\u662fGMP\u5ba1\u6838\u5458”\u3002\u4e24\u53e5\u8bdd\u90fd\u7b26\u5408\u4e2d\u6587\u7684\u8bed\u6cd5\u548c\u8bed\u4e49\u3002 \u4f46\u5b9e\u9645\u4e0a\u8fd9\u4e24\u4e2a\u53e5\u5b50\u91cc\u7684”\u786e\u8ba4”\u7684\u610f\u601d\u662f\u4e0d\u540c\u7684\u3002 \u524d\u4e00\u53e5\u7684\u610f\u601d\u662f”Qualify”\uff0c\u800c\u540e\u4e00\u53e5\u7684\u610f\u601d\u662f”Verify”\u3002\u8fd9\u5c31\u662f\u5176\u7ffb\u8bd1\u7684\u95ee\u9898\u4e4b\u6240\u5728\u3002<\/span><\/h3>\n


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Qualification\u548cVerification\u7684\u533a\u522b\u662f\uff1aQualification\u7684\u52a8\u4f5c\u4e2d\u6ca1\u6709\u4e00\u4e2a\u5df2\u5b58\u5728\u7684\u4e8b\u5b9e\u6216\u8bf4\u6cd5\uff0c\u53ea\u6709\u9884\u5148\u8bbe\u5b9a\u7684\u6807\u51c6\uff08\u8fd9\u4e9b\u6807\u51c6\u662f\u5426\u901a\u8fc7\u8fd8\u4e0d\u77e5\u9053\uff0c\u9700\u8981\u88abVerify\uff09\u3002Qualification\u7684\u8fc7\u7a0b\u5c31\u662f\u901a\u8fc7\u6d4b\u8bd5\u6216\u8bd5\u9a8c\u53bb\u5efa\u7acb\u8fd9\u4e2a\u4e8b\u5b9e\u5e76\u5f97\u51fa\u7ed3\u8bba\u3002\u800c\u8fd9\u4e2a”\u6d4b\u8bd5”\u6216”\u8bd5\u9a8c”\u7684\u8fc7\u7a0b\u5219\u901a\u5e38\u662f\u901a\u8fc7”verification”\u6765\u8fbe\u5230\u7684\u3002\u6bd4\u5982\u4e0a\u9762\u7684\u4f20\u611f\u5668\u7684\u4f8b\u5b50\uff0c\u9884\u5148\u5047\u8bbe\u7684\u4e8b\u5b9e\u662f”\u5982\u679c\u6761\u7801\u662f\u9519\u8bef\u7684\uff0c\u6807\u7b7e\u4f1a\u88ab\u5254\u9664”\u3002Qualification\u7684\u52a8\u4f5c\u5c31\u662f\u7528\u9519\u8bef\u7684\u6761\u7801\uff0c\u89c2\u5bdf\u6807\u7b7e\u662f\u5426\u88ab\u5254\u9664\u3002 \u82e5\u8bbe\u5907\u5254\u9664\u4e86\u8be5\u6807\u7b7e\uff0c\u5219\u8be5\u4f20\u611f\u5668\u901a\u8fc7Qualification\u3002\u4e4b\u540e\u8fd9\u4e2a”\u9519\u8bef\u6761\u7801\u7684\u6807\u7b7e\u4f1a\u88ab\u8be5\u4f20\u611f\u5668\u5254\u9664”\u7684\u4e8b\u5b9e\u5c31\u5efa\u7acb\u5e76\u5b58\u5728\u4e86\u3002\u4ee5\u540e\u5c31\u53ef\u4ee5verify\u8fd9\u4e2a\u4e8b\u5b9e\u662f\u5426\u6210\u7acb\u3002<\/span><\/h3>\n


<\/h3>\n

\u5173\u4e8eQualification\u7684\u539f\u610f\u7684\u53e6\u4e00\u5c24\u5176\u91cd\u8981\u7684\u4e00\u70b9\u662f\uff1aQualification\u7684\u52a8\u4f5c\u662f\u5047\u8bbe”\u5f53\u8fbe\u5230\u4e86\u4e00\u5b9a\u7684\u6807\u51c6\u65f6\u5c31\u4e00\u5b9a\u53ef\u4ee5\u505a\u67d0\u4ef6\u4e8b\u60c5”\u3002  \u8fd8\u662f\u7528\u524d\u9762\u4f20\u611f\u5668\u7684\u4f8b\u5b50\u6765\u8bf4\u660e\uff1a\u8981Qualify\u8fd9\u4e2a\u4f20\u611f\u5668\uff0c\u53ea\u8981\u6d4b\u8bd5\u4e00\u6b21\uff0c\u5f97\u5230\u6b63\u786e\u7ed3\u679c\uff0c\u6211\u4eec\u5c31\u9ed8\u8ba4\uff1a\u8fd9\u4e2a\u4f20\u611f\u5668\u88abQualified\u4e86\uff0c\u800c\u4e14\u4ee5\u540e\u6bcf\u6b21\u6709\u9519\u8bef\u6216\u4e0d\u53ef\u8bfb\u7684\u6807\u7b7e\uff0c\u8be5\u8bbe\u5907\u90fd\u4f1a\u5c06\u5176\u5254\u9664\u3002  \u8bf7\u6ce8\u610f\u8fd9\u662f\u4e2a\u9690\u542b\u7684\u5047\u8bbe\u3002  \u7406\u89e3Qualification\u7684\u8fd9\u4e00\u5c42\u4e0d\u8a00\u800c\u55bb\u7684\u5047\u8bbe\u5bf9\u4e8e\u7406\u89e3Qualification\u548cValidation \u7684\u533a\u522b\u6781\u4e3a\u91cd\u8981\uff0c\u56e0\u4e3a\u4ece\u67d0\u79cd\u610f\u4e49\u4e0a\u8bb2\uff0cValidation\u5c31\u662f\u5bf9Qualification\u4e2d\u7684\u8fd9\u4e2a\u4e0d\u8a00\u800c\u55bb\u7684\u5047\u8bbe\u8fdb\u884c\u8bc1\u660e\u3002<\/span><\/h3>\n
\n
\n
Validation<\/section>\n<\/section>\n<\/section>\n

\u8fd9\u4e2a\u8bcd\u5927\u5bb6\u66f4\u719f\u6089\uff0c\u751a\u81f3\u6709\u70b9\u5ac9\u6068\u5b83\u3002\u5b83\u6765\u81ea\u4e8evalidate\uff0c\u610f\u601d\u662f\u201cto prove that something is right, true or correct\uff0c\u8bc1\u660e\u67d0\u4e2a\u4e1c\u897f\u662f\u5bf9\u7684\u201d\u3002\u8bf7\u6ce8\u610fVerification\u7684\u610f\u601d\u662f\u201cto find out a fact or statements\u2026etc. is true\u201d\u3002 \u82f1\u8bed\u91cc\u201cto prove\u201d\u548c\u201cto find out\u201d\u662f\u6709\u533a\u522b\u7684\uff1a\u524d\u8005\u662f\u8981\u5efa\u7acb\u4e8b\u5b9e\u6765\u8bc1\u660e\uff0c\u800c\u540e\u8005\u9690\u542b\u4e8b\u5b9e\u5df2\u7ecf\u5b58\u5728\uff0c\u53ea\u662f\u628a\u5b83\u627e\u51fa\u6765\u3002\u5b8c\u6210\u4e86Qualification\u5c31\u8bc1\u660e\u4e86\u4e00\u4e9b\u5de5\u827a\u5355\u5143\u53ef\u4ee5\u8fbe\u5230\u4e86\u505a\u67d0\u9879\u5de5\u4f5c\u7684\u6807\u51c6\uff0c\u90a3\u4e48\u5c06\u8fd9\u4e9b\u5355\u5143\u8fde\u63a5\u5230\u4e00\u8d77\uff0c\u5b83\u4eec\u662f\u5426\u4ecd\u53ef\u4ee5\u6b63\u5e38\u5de5\u4f5c\uff1f\u5c24\u5176\u91cd\u8981\u7684\u662f\u5b83\u4eec\u662f\u5426\u53ef\u4ee5\u91cd\u590d\uff08reproducibly\uff09\u5730\u6b63\u5e38\u5de5\u4f5c\uff0c\u5e76\u8fbe\u5230\u8981\u6c42\uff0c\u8fd9\u5c31\u662fValidation\u8981\u505a\u7684\u5de5\u4f5c\u3002 \u5373\u5bf9\u5df2\u901a\u8fc7\u201cQualification\u201d\u7684\u8bbe\u5907\uff0c\u6750\u6599\uff0c\u4eba\u5458\uff0c\u73af\u5883\u7b49\u7b49\u7684\u56e0\u7d20\u8fdb\u884c\u6574\u4f53\u7684\u6d4b\u8bd5\u3002\u8fd9\u4e5f\u662f\u4e3a\u4ec0\u4e48Qualification\u4e0d\u80fd\u591f\u4ee3\u66ffValidation\u7684\u539f\u56e0\u4e4b\u6240\u5728\u3002WHO GMP\u7684Annex4\u4e13\u95e8\u5bf9\u6b64\u505a\u4e86\u8bf4\u660e\u201cthe individual qualification steps alone do not constitute process validation\u201d\u2465\u3002<\/span><\/h3>\n


<\/h3>\n

\u4e0b\u9762\u8fd9\u4e2a\u4f8b\u5b50\u53ef\u4ee5\u5e2e\u52a9\u7406\u89e3Qualification\u548cValidation\u7684\u533a\u522b\uff1a\u201cYou can qualify Tom to be a GMP auditor, but you cannot validate Tom\u201d\u3002\u610f\u601d\u662f\u201c\u6211\u4eec\u53ef\u4ee5\u628a\u5f20\u4e09\u57f9\u517b\u6210\u4e00\u4e2aGMP\u5ba1\u6838\u5458\uff0c\u4f46\u662f\u6211\u4eec\u4e0d\u53ef\u80fd\u5bf9\u5f20\u4e09\u8fdb\u884c\u9a8c\u8bc1\u201d\uff0c\u4e5f\u5c31\u662f\u4e0d\u53ef\u80fd\u4fdd\u8bc1\u5f20\u4e09\u59cb\u7ec8\u505a\u597d\u5408\u683c\u7684GMP\u5ba1\u6838\u5458\u3002<\/span><\/h3>\n


<\/h3>\n

\u7406\u89e3\u4e86Verification\uff0cQualification\u548cValidation\u8fd9\u4e09\u4e2a\u82f1\u8bed\u5355\u8bcd\u7684\u610f\u4e49\u4e0a\u7684\u533a\u522b\uff0c\u5c31\u66f4\u5bb9\u6613\u7406\u89e3Qualification\u548cValidation\u5728GMP\u5de5\u4f5c\u4e2d\u7684\u533a\u522b\u3002<\/span><\/h3>\n
\n
\n
Qualification\u548cValidation\u5728GMP\u5de5\u4f5c\u4e2d\u7684\u533a\u522b<\/section>\n<\/section>\n<\/section>\n

Qualification\u603b\u662f\u5bf9\u4e8e\u5177\u4f53\u7684\u5b9e\u7269\u800c\u8a00\uff0c\u901a\u5e38\u5305\u62ec\u5382\u623f\uff08facilities\uff09\u3001\u8bbe\u65bd\uff08utilities\uff09\u548c\u8bbe\u5907\uff08equipment\uff09\u3002\u6bd4\u5982Qualify\u4e00\u4e2aD\u7ea7\u533a\u623f\u95f4\uff0c\u4e00\u53f0HPLC\uff0c\u4e00\u4e2a\u6e7f\u70ed\u706d\u83cc\u9505\uff0c\u4e00\u53f0\u5929\u5e73\uff0c\u4e00\u53f0\u8d34\u7b7e\u673a\uff0c\u4e00\u53f0\u538b\u7247\u673a\uff0c\u7eaf\u6c34\u7cfb\u7edf\uff0c\u538b\u7f29\u7a7a\u6c14\u7cfb\u7edf\uff0c HVAC\u7b49\u7b49\u3002\u5728\u5bf9\u8fd9\u4e9b\u76ee\u6807\u7269\u8fdb\u884cQualification\u4e4b\u524d\u4e00\u5b9a\u4f1a\u6709\u4e00\u5957\u9884\u5148\u8bbe\u5b9a\u7684\u5404\u81ea\u7684\u6807\u51c6\uff08URS\u6216\u6027\u80fd\u6307\u6807\uff09\u3002\u800cQualification\u5de5\u4f5c\u5f80\u5f80\u90fd\u662f\u901a\u8fc7\u4e00\u7cfb\u5217\u7684Verification\u6d3b\u52a8\uff08\u6d4b\u8bd5\u3001\u8bd5\u9a8c\u3001\u6838\u5b9e\u7b49\u7b49\uff09\u6765\u68c0\u67e5\u76ee\u6807\u7269\u662f\u5426\u8fbe\u5230\u4e86\u9884\u5148\u8bbe\u5b9a\u7684\u8981\u6c42\u3002\u901a\u5e38\u6765\u8bf4\uff0cQualification\u5c31\u662f\u4e00\u7cfb\u5217\u7684Verification\u5de5\u4f5c\u3002\u6b27\u76dfGMP\u7684Annex15\u4e2d\u5173\u4e8eIQ\u3001OQ\u548cPQ\u7684\u5b9a\u4e49\u90fd\u662f”The documented verification that\u2026”\uff0c\u5176\u4e2dIQ\u4e2d\u76845\u9879\u5de5\u4f5c\u4e2d3\u9879\u662f”Verification  of\u2026”\u2461\u3002\u8fd9\u4e9b\u90fd\u5145\u5206\u5730\u4f53\u73b0\u4e86Qualification\u662f\u901a\u8fc7Verification\u6765\u5b8c\u6210\u7684\u3002\u56e0\u6b64\u6211\u4eec\u603b\u662f\u8bf4”\u8bbe\u5907\u786e\u8ba4”\uff0c\u800c\u4e0d\u8bf4”\u8bbe\u5907\u9a8c\u8bc1”\u3002\u5426\u5219\uff0c\u542c\u8d77\u6765\u5c31\u662f\u5916\u884c\u3002<\/span><\/h3>\n

Validation\u7684\u76ee\u6807\u4f53\u603b\u662f\u5de5\u827a\u3001\u65b9\u6cd5\u6216\u89c4\u7a0b\uff0c\u56e0\u4e3a\u5b83\u4eec\u7684\u7ed3\u679c\u901a\u5e38\u4e0d\u80fd\u88abverify\u3002\u5b9e\u9645\u4e0a\u7f8e\u56fdFDA\u7684\u533b\u7597\u5668\u68b0GMP\uff0cCFR21.820.75 (a) \u6307\u51fa\uff1a”Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated\u5982\u679c\u4e00\u4e2a\u5de5\u827a\u7684\u7ed3\u679c\u4e0d\u80fd\u88ab\u5b8c\u5168verify\u7684\u8bdd\uff0c\u8be5\u5de5\u827a\u8981\u88ab\u9a8c\u8bc1”\u2463\u3002\u53cd\u4e4b\uff0c\u5982\u679c\u4e00\u4e2a\u5de5\u827a\u7684\u7ed3\u679c\u80fd\u88ab\u5b8c\u5168verify\u7684\u8bdd\uff0c\u8be5\u5de5\u827a\u5c31\u4e0d\u5fc5\u88ab\u9a8c\u8bc1\u3002\u6bd4\u65b9\u706d\u83cc\u8fc7\u7a0b\u7684\u7ed3\u679c\u662f\u4e0d\u53ef\u80fd\u88ab\u5b8c\u5168verify\uff0c\u56e0\u4e3a\u5982\u679c\u8981verify\u7684\u8bdd\uff0c\u90a3\u5c31\u5bf9\u4ea7\u54c1\u8fdb\u884c\u57f9\u517b\u3002\u90a3\u6837\u7684\u8bdd\u4ea7\u54c1\u7684\u65e0\u83cc\u72b6\u6001\u6216\u4ea7\u54c1\u672c\u8eab\u5c31\u5fc5\u7136\u4f1a\u88ab\u7834\u574f\u4e86\uff08\u6ce8\u610f\u8fd9\u91cc”\u5b8c\u5168”\u8fd9\u4e2a\u8bcd\uff0c\u53d6\u6837\u6d4b\u8bd5\u6c38\u8fdc\u4e0d\u662f”\u5b8c\u5168”\uff09\u3002\u518d\u6bd4\u65b9CIP\uff08\u6e05\u6d01\uff09\uff0c\u5982\u679c\u60f3Verify\u5176\u6e05\u6d01\u7684\u7ed3\u679c\uff0c\u5c31\u8981\u6253\u5f00\u8bbe\u5907\uff0c\u53d6\u6837\uff0c\u68c0\u6d4b\u3002\u8fd9\u540c\u6837\u4f1a\u7834\u574f\u8bbe\u5907\u7684\u6e05\u6d01\u72b6\u6001\u3002\u6240\u4ee5\u8fd9\u4e9b\u8fc7\u7a0b\uff08\u706d\u83cc\uff0c\u6e05\u6d01\u7b49\u7b49\uff09\u53ea\u80fd\u901a\u8fc7\u9a8c\u8bc1\u6765\u786e\u4fdd\u8fd9\u4e9b\u8fc7\u7a0b\u7684\u7ed3\u679c\u662f\u6709\u6548\u7684\u3002<\/span><\/h3>\n


<\/h3>\n

\u6709\u8da3\u7684\u662f\u6b27\u76dfAnnex15\u2461\u548c\u7f8e\u56fdFDA\u5de5\u827a\u9a8c\u8bc1\u7684\u6307\u5357\u2462\u4e2d\u5747\u6ca1\u6709”Qualification”\u548c”Validation”\u7684\u540d\u8bcd\u89e3\u91ca\uff0c\u597d\u50cf\u662f\u6545\u610f\u9003\u907f\u5bf9\u8fd9\u4e24\u4e2a\u8bcd\u7684\u89e3\u91ca\u3002WHO\u7684GMP Annex 4 \u2465\u65e2\u6709Qualification\u7684\u5b9a\u4e49\uff0c\u4e5f\u6709Validation\u7684\u5b9a\u4e49\u3002\u89c1\u4e0b\uff1a<\/span><\/h3>\n

\"\u8d28\u91cf\u4eba\u5fc5\u8bfb|Qualification<\/p>\n

“\u786e\u8ba4–\u8bc1\u660e\u5e76\u8bb0\u5f55\u5382\u623f\u3001\u7cfb\u7edf\u548c\u8bbe\u5907\u88ab\u6b63\u786e\u5b89\u88c5\uff0c\u5e76\u4e14\u6216\u8005\u8fd0\u884c\u6b63\u5e38\uff0c\u5e76\u80fd\u8fbe\u5230\u9884\u671f\u7ed3\u679c\u7684\u884c\u52a8\u3002 \u786e\u8ba4\u901a\u5e38\u662f\u9a8c\u8bc1<\/span>\uff08\u6700\u521d\u9636\u6bb5\uff09\u7684\u4e00\u4e2a\u90e8\u5206\uff0c\u4f46\u662f\u5355\u4e2a\u786e\u8ba4\u672c\u8eab\u4e0d\u80fd\u5f62\u6210\u5de5\u827a\u9a8c\u8bc1”<\/span>\u3002<\/span><\/h3>\n

WHO\u5728Qualification\u7684\u540d\u8bcd\u89e3\u91ca\u4e2d\u91cd\u7533\uff1a\u786e\u8ba4\u4e0d\u80fd\u4ee3\u66ff\u5de5\u827a\u9a8c\u8bc1\u3002\u4f46\u8bf7\u6ce8\u610f\u9ed1\u4f53\u5b57\u7684\u533a\u522b\uff1a\u524d\u534a\u90e8\u5206\u662f”\u9a8c\u8bc1<\/span>“\uff0c\u540e\u534a\u90e8\u5206\u662f”\u5de5\u827a\u9a8c\u8bc1<\/span>“\uff08\u4ed6\u4eec\u4e5f\u73a9\u6587\u5b57\u6e38\u620f\u7684\uff09\u3002<\/span><\/h3>\n

\"\u8d28\u91cf\u4eba\u5fc5\u8bfb|Qualification<\/p>\n

WHO\u5173\u4e8e\u9a8c\u8bc1\u7684\u5b9a\u4e49\u5f3a\u8c03\u4e86”\u5de5\u827a\u3001\u89c4\u7a0b\u6216\u65b9\u6cd5\uff1a\uff0c\u5e76\u4e14\u8981\u6c42”\u4e00\u8d2f\u5730”\u3002  \u89c1\u4e0b\uff1a”\u8bc1\u660e\u5e76\u8bb0\u5f55\u5de5\u827a\u3001\u89c4\u7a0b\u6216\u65b9\u6cd5\u80fd\u5b9e\u9645\u4e14\u4e00\u8d2f\u5730<\/span>\u8fbe\u5230\u9884\u671f\u7ed3\u679c\u7684\u884c\u52a8”\u3002<\/span><\/h3>\n

\u4e2d\u56fdGMP2010\u7248\u2460\u4e2d\u7b2c312\u6761\u672f\u8bed\uff08\u4e09\u5341\u4e8c\uff09\u5bf9”\u786e\u8ba4”\u7684\u89e3\u91ca\u662f”\u8bc1\u660e\u5382\u623f\u3001\u8bbe\u65bd\u3001\u8bbe\u5907\u80fd\u6b63\u786e\u8fd0\u884c\u5e76\u53ef\u8fbe\u5230\u9884\u671f\u7ed3\u679c\u7684\u4e00\u7cfb\u5217\u6d3b\u52a8”\uff1b\u672f\u8bed\uff08\u4e09\u5341\u516b\uff09\u5bf9”\u9a8c\u8bc1”\u7684\u89e3\u91ca\u662f”\u8bc1\u660e\u4efb\u4f55\u64cd\u4f5c\u89c4\u7a0b\uff08\u6216\u65b9\u6cd5\uff09\u3001\u751f\u4ea7\u5de5\u827a\u6216\u7cfb\u7edf\u80fd\u591f\u8fbe\u5230\u9884\u671f\u7ed3\u679c\u7684\u4e00\u7cfb\u5217\u6d3b\u52a8”\u3002\u8fd9\u4e24\u4e2a\u89e3\u91ca\u9664\u4e86\u5c06”\u5382\u623f\u3001\u8bbe\u65bd\u3001\u8bbe\u5907”\u6362\u6210\u4e86”\u64cd\u4f5c\u89c4\u7a0b\uff08\u6216\u65b9\u6cd5\uff09\u3001\u751f\u4ea7\u5de5\u827a\u6216\u7cfb\u7edf”\u5916\uff0c\u5176\u4ed6\u57fa\u672c\u4e00\u6837\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff1a\u6b27\u76df\u548cWHO\u7684GMP\u90fd\u628aValidation\u548c”\u5de5\u827a\u3001\u89c4\u7a0b\u548c\u65b9\u6cd5”\u76f8\u8fde\uff0c\u628aQualification\u548c”\u5382\u623f\u3001\u8bbe\u65bd\u3001\u8bbe\u5907\u548c\u7cfb\u7edf”\u76f8\u8fde\u3002\u800c\u4e2d\u56fdGMP\u2460\u5219\u628a”\u7cfb\u7edf”\u632a\u5230\u548cValidation\u76f8\u8fde\u3002  \u4e2d\u56fdGMP2010\u7248\u5bf9”\u9a8c\u8bc1”\u8fd9\u4e2a\u672f\u8bed\u89e3\u91ca\u7684\u81f4\u547d\u70b9\u662f\u7f3a\u5c11\u4e86\u4e00\u4e2a\u5173\u952e\u7684\u8bcd”reproducibly”or  “Consistently”\u5373”\u91cd\u590d\u5730”\u6216”\u4e00\u8d2f\u5730”\u3002\u6ca1\u6709\u8fd9\u4e2a\u5173\u952e\u8bcd\uff0c\u8fd9\u4e24\u4e2a\u8bcd\uff08Qualification\u548cValidation\uff09\u7684\u533a\u522b\u6781\u5176\u4e0d\u660e\u663e\uff0c\u8fd9\u4e5f\u53ef\u80fd\u662f\u4e3a\u4ec0\u4e48\u4f1a\u6709\u8bb8\u591a\u540c\u4e8b\u5bf9\u8fd9\u4e24\u4e2a\u8bcd\u533a\u522b\u4e0d\u6e05\u3002<\/span><\/h3>\n


<\/h3>\n

\u7efc\u4e0a\u53ef\u89c1\uff0cQualification\u548cValidation\u8fd8\u662f\u6709\u533a\u522b\u7684\u3002 Qualification\u603b\u662f\u5bf9\u4e8e\u5177\u4f53\u7684\u5b9e\u7269\u800c\u8a00\uff0c\u800c\u9a8c\u8bc1\uff08Validation\uff09\u7684\u76ee\u6807\u4f53\u603b\u662f\u5de5\u827a\u3001\u65b9\u6cd5\u6216\u89c4\u7a0b\u3002\u5373\u901a\u5e38”\u8bbe\u5907\u786e\u8ba4”\u548c”\u5de5\u827a\u9a8c\u8bc1”\u7684\u8bf4\u6cd5\u662f\u6709\u9053\u7406\u7684\u3002  Qualification\u662f\u9a8c\u8bc1\u7684\u4e0d\u53ef\u7f3a\u5c11\u7684\u4e00\u4e2a\u90e8\u5206\uff0c\u4e0d\u8fc7\u5176\u672c\u8eab\u5e76\u4e0d\u80fd\u4ee3\u66ff\u5de5\u827a\u9a8c\u8bc1\u3002  Qualification\u901a\u5e38\u901a\u8fc7Verification\u6765\u8fbe\u5230\uff0c\u4e0d\u5f3a\u8c03\u91cd\u590d\uff1b\u800cValidation\u4e00\u5b9a\u8981\u5f3a\u8c03\u91cd\u590d\u3002<\/span><\/h3>\n
\n
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Qualification\u548cValidation\u6982\u5ff5\u7684\u65b0\u8fdb\u5c55<\/section>\n<\/section>\n<\/section>\n

\u53ef\u662fQualification\u548cValidation\u7684\u533a\u522b\u8d8a\u6765\u8d8a\u88ab\u8fd1\u51e0\u5e74\u7684\u65b0\u8fdb\u5c55\u6240\u6311\u6218\u3002 \u8bb8\u591a\u4e1a\u754c\u7684\u4e13\u5bb6\u5305\u62ec\u76d1\u7ba1\u6743\u5a01\u4eba\u58eb\u90fd\u4f1a\u8ba4\u4e3aQualification\u548cValidation\u7684\u754c\u9650\u9010\u6e10\u6a21\u7cca\u3002\u4f8b\u5982WHO\u7684Annex4\u4e2d\u7684\u8868\u8ff0\u662f”validation and qualification of premises, equipment, utilities and\u3000systems, and processes and procedures\u2465”\uff08\u6ce8\u610f\u4e0b\u5212\u7ebf\u7684\u8bcd\u6216\u8bcd\u7ec4\u662f\u5e76\u5217\u5173\u7cfb\uff09\u3002\u5176\u7b2c\u56db\u8282\u4e13\u95e8\u6307\u51fa\uff1a “Qualification\u548cValidation\u672c\u8d28\u4e0a\u662f\u540c\u4e00\u4e2a\u6982\u5ff5\u7684\u7ec4\u6210\u90e8\u5206\u3002Qualification\u901a\u5e38\u7528\u4e8e\u8bbe\u5907\u3001\u8bbe\u65bd\u548c\u7cfb\u7edf\uff0c\u800cValidation\u7528\u4e8e\u5de5\u827a\u3002\u4ece\u8fd9\u4e2a\u610f\u4e49\u4e0a\u8bb2\uff0cQualification\u662fValidation\u7684\u4e00\u90e8\u5206\u2463”\uff0c\u89c1\u4e0b\u56fe\uff08WHO\u7684Annex\u4e2d\u7684\u8fd9\u4e00\u8282\u5c31\u8fd9\u4e09\u53e5\u8bdd\uff09\u3002<\/span><\/h3>\n

\"\u8d28\u91cf\u4eba\u5fc5\u8bfb|Qualification<\/p>\n

\u66f4\u6709\u751a\u8005\uff0c\u7f8e\u56fdFDA 2011\u5de5\u827a\u9a8c\u8bc1\u6307\u5357\u2462\u51fa\u73b0\u4e86\u201cProcess Qualification\u201d\u7684\u6982\u5ff5\uff0c\u4f7f\u5f97\u591a\u5e74\u7684\u201c\u8bbe\u5907\u786e\u8ba4\u201d\u548c\u201c\u5de5\u827a\u9a8c\u8bc1\u201d\u7684\u8bf4\u6cd5\u88ab\u5f7b\u5e95\u98a0\u8986\u3002 \u57282017\u5e74\u7f8e\u56fdFDA\u53d1\u51fa\u7684\u4e00\u5c01\u8b66\u544a\u4fe1\u2467\u4e2d\u4e5f\u51fa\u73b0\u4e86\u201cProcess Qualification study\u201d\u7684\u8bf4\u6cd5\uff08\u89c1\u4e0b\u56fe\uff09\u3002<\/span><\/h3>\n

\"\u8d28\u91cf\u4eba\u5fc5\u8bfb|Qualification<\/p>\n

\"\u8d28\u91cf\u4eba\u5fc5\u8bfb|Qualification<\/p>\n

\u90a3\u4e48\u5de5\u827a\u662f\u5426\u771f\u7684\u53ef\u4ee5\u88ab\u201cQualify\u201d\u5417\uff1f\u6216\u8005\u8bf4\u5982\u679c\u5de5\u827a\u53ef\u4ee5\u88abQualify\uff0c\u5982\u4f55\u505a\u5462\uff1f\u8981\u56de\u7b54\u8fd9\u4e2a\u95ee\u9898\u9996\u5148\u8981\u770b\u770bFDA2011\u5de5\u827a\u9a8c\u8bc1\u6307\u5357\u2462\u91cc\u7684\u5bf9\u201cProcess  Qualification\u201d\u7684\u5b9a\u4e49\uff0c\u5982\u4e0b\u56fe\uff1a<\/span><\/h3>\n

\u610f\u601d\u662f\u201c\u8bc1\u5b9e\u5df2\u8bbe\u8ba1\u597d\u7684\u5236\u836f\u5de5\u827a\u6709\u80fd\u529b\u8fdb\u884c\u91cd\u590d\u7684\u5546\u4e1a\u5316\u751f\u4ea7\u201d\u2462\u3002\u9996\u5148\uff0c\u8fd9\u91cc\u7684\u5173\u952e\u8bcd\u662f\u201creproducible\u91cd\u590d\u7684\u201d\u3002\u901a\u8fc7\u524d\u9762\u7684\u89e3\u91ca\u6211\u4eec\u77e5\u9053\u201cQualification\u201d\u4e0d\u5f3a\u8c03\u91cd\u590d\uff0c\u800c\u8fd9\u91cc\u6070\u6070\u5f3a\u8c03\u201c\u91cd\u590d\u201d\uff0c\u53ef\u89c1\u672c\u8d28\u4e0a\u8fd9\u4e2a\u5b9a\u4e49\u4e0e\u201cValidation\u201d\u7684\u66f4\u63a5\u8fd1\u3002\u5176\u6b21\uff0c\u8fd9\u4e2a\u5b9a\u4e49\u662f\u57fa\u4e8eFDA\u6307\u5357\u7684\u7279\u6b8a\u8bed\u5883\u800c\u5b9a\u4e49\u7684\uff0c\u89c1\u4e0b\u56fe\uff1a<\/span><\/h3>\n

\"\u8d28\u91cf\u4eba\u5fc5\u8bfb|Qualification<\/p>\n

\u7531\u56fe\u53ef\u89c1FDA 2011\u6307\u5357\u2462\u628a\u201cProcess Validation\u5de5\u827a\u9a8c\u8bc1\u201d\u8fd9\u4e2a\u8bcd\u7684\u5916\u5ef6\u6269\u5927\u4e86\uff0c\u5373\u628a\u5de5\u827a\u9a8c\u8bc1\u5411\u524d\u6269\u5c55\u5230\u5de5\u827a\u8bbe\u8ba1\uff0c\u5411\u540e\u5305\u62ec\u5bf9\u5546\u4e1a\u5316\u751f\u4ea7\u4e2d\u59cb\u7ec8\u4fdd\u6301\u5de5\u827a\u7684\u9a8c\u8bc1\u72b6\u6001\u3002\u66f4\u91cd\u8981\u7684\u662f\u8fd9\u4e2a\u6269\u5c55\u7684\u5de5\u827a\u9a8c\u8bc1\u7684\u6982\u5ff5\u4e0d\u518d\u5c06\u5de5\u827a\u9a8c\u8bc1\u770b\u6210\u662f\u4e00\u4e2a\u4e00\u6b21\u6027\u7684\u5de5\u4f5c\uff0c\u8fd9\u6b63\u662fFDA2011\u6307\u5357\u7684\u6839\u672c\u76ee\u7684\u2466\u3002 \u800c\u4f20\u7edf\u610f\u4e49\u4e0a\u7684\u201c\u786e\u8ba4\u201d\u5305\u62ec\u5bf9\u5382\u623f\u3001\u8bbe\u5907\u3001\u8bbe\u65bd\u7684\u786e\u8ba4\uff0c\u539f\u672c\u662f\u4f20\u7edf\u201c\u5de5\u827a\u9a8c\u8bc1\u201d\u7684\u524d\u63d0\uff0c\u73b0\u5728\u88ab\u4f5c\u4e3a\u201cStage 2\u201d\u7684\u7b2c\u4e00\u6b65\uff1b\u4f20\u7edf\u610f\u4e49\u4e0a\u7684\u201c\u5de5\u827a\u9a8c\u8bc1\u201d\u5c31\u662f\u56fe\u4e2d\u7684\u201cStage 2\u201d\u7684\u7b2c\u4e8c\u6b65\u201c\u5de5\u827a\u7ee9\u6548\u786e\u8ba4\uff08PPQ\uff09\u201d\u3002\u90a3\u4e48\uff0c\u95ee\u9898\u662f\u201cStage 2\u201d\u5230\u5e95\u5e94\u8be5\u53eb\u4ec0\u4e48\uff1f \u7b14\u8005\u6597\u80c6\u8ba4\u4e3a\uff1a\u56e0\u4e3a\u7b2c\u4e8c\u9636\u6bb5\u4e2d\u7684\u4e24\u4e2a\u65b9\u9762\u90fd\u662f\u201cQualification\u786e\u8ba4\u201d\uff08\u89c1\u4e0a\u56fe\uff09\uff0c\u6240\u4ee5\u8fd9\u4e2a\u9636\u6bb5\u7406\u5e94\u88ab\u79f0\u4e3a\u201cProcess Qualification\u5de5\u827a\u786e\u8ba4\u201d\uff0c\u7f29\u5199\u4e3aPQ\u3002\u4f46\u8fd9\u7edd\u5bf9\u4e0d\u610f\u5473\u7740\u201c\u5de5\u827a\u53ef\u4ee5\u88ab\u2018Qualify\u2019\uff08\u89c1\u4e0b\u6587\uff09\uff01 \u800c\u662f\u5de5\u827a\u7684performance\uff08\u7ee9\u6548\uff09\u53ef\u4ee5\u88abQualify\u3002\u6ce8\u610f\uff1a\u8fd9\u91cc\u7684PQ\u548c\u4f20\u7edf\u7684\u88ab\u5927\u5bb6\u719f\u8bc6\u7684PQ\uff08Performance Qualification\uff09\u662f\u5b8c\u5168\u4e24\u7801\u4e8b\uff01 Performance Qualification\u662f\u4f20\u7edf\u7684Qualification\u4e2d\u7684\u4e00\u4e2a\u90e8\u5206\uff0c\u6b27\u76df\u7684Annex15\u4e2d\u4ecd\u7136\u4fdd\u7559\u4e86\u8fd9\u4e2a\u8bcd\uff08\u53ef\u89c1they never make our life easy\uff01\uff09\u3002<\/span><\/h3>\n


<\/h3>\n

\u5982\u679c\u4e0a\u9762\u5173\u4e8eProcess Qualification\u7684\u89e3\u91ca\u8fd8\u4e0d\u5145\u5206\uff0c\u90a3\u4e48\u6700\u540e\uff0c\u8bf7\u53d1\u6325\u6211\u4eec\u7684\u60f3\u8c61\u529b\uff1a\u6211\u4eec\u628a\u4e00\u4e2a\u5de5\u827a\u770b\u6210\u4e00\u4e2a\u5b9e\u4f53\u7269\uff0c\u90a3\u4e48Stage 1\u5c31\u50cf\u662f\u5bf9\u8fd9\u4e2a\u5b9e\u4f53\u7684\u719f\u77e5\u8fc7\u7a0b\uff0c\u7c7b\u4f3c\u65b0\u8bbe\u5907\u7684commissioning\u3002Stage 2\u5219\u662f\u5bf9\u5176\u8fdb\u884cQualification\uff0c\u4e0d\u8fc7\u8fd9\u91cc\u662f\u5bf9\u5de5\u827a\u7684\u201cperformance\u7ee9\u6548\u201d\u8fdb\u884cQualification\uff0c\u6240\u4ee5\u9664\u4e86\u5e38\u89c4\u7684\u8bbe\u65bd\u548c\u8bbe\u5907Qualification\uff08IQ\uff0cOQ\u548cPQ\uff09\u4e4b\u5916\uff0c\u8fd8\u8981\u8003\u5bdf\u5de5\u827a\u7684\u201c\u53ef\u91cd\u590d\u6027\u201d\uff0c\u4e5f\u5c31\u662f\u901a\u5e38\u91c7\u7528\u201c\u4e09\u6279\u9a8c\u8bc1\u6279\u201d\uff08\u5176\u5b9e\u76ee\u524d\u8bb8\u591a\u516c\u53f8\u7684PPQ\u4ecd\u7136\u662f\u201c\u4e09\u6279\u9a8c\u8bc1\u6279\u201d\uff0c\u800c\u4e14FDA\u7684\u5ba1\u8ba1\u7f3a\u9677\u9879\u4e2d\u5e76\u6ca1\u6709\u5173\u4e8e\u8fd9\u65b9\u9762\u7684\u53d1\u73b0\u9879\u3002\u53ef\u89c1\u201c\u4e09\u6279\u9a8c\u8bc1\u6279\u201d\u4ecd\u662f\u9ed8\u8bb8\u7684\uff09\u6765\u786e\u8ba4\u5de5\u827a\u7684\u521d\u59cb\u53ef\u91cd\u590d\u6027\uff0c\u5373\u5de5\u827a\u7ee9\u6548\u786e\u8ba4\uff08PPQ\uff09\u3002 \u7136\u540eStage 3\u662f\u6b63\u5e38\u751f\u4ea7\u3002 \u56e0\u4e3a\u8fd9\u65f6\u7684\u5de5\u827a\u5df2\u7ecf\u7ecf\u8fc7\u521d\u59cb\u7684\u201c\u9a8c\u8bc1\u201d\u4e86\uff0c\u4e5f\u5c31\u53ef\u4ee5\u8bf4Stage 3\u7684\u201c\u4ea7\u54c1\u662f\u5728\u9a8c\u8bc1\u7684\u72b6\u6001\u4e0b\u751f\u4ea7\u7684\u201d\uff0c\u6240\u4ee5Stage 3\u53ea\u9700\u8981\u5bf9\u8fd9\u4e2a\u201c\u8bf4\u6cd5\u201d\u8fdb\u884c\u201cVerification\u201d\u3002  \u4f46\u8fd9\u4e2aVerification\u4e5f\u4e0d\u662f\u4e00\u6b21\u6027\u7684\uff0c\u6545\u9700\u8981\u201cContinued\u201d\uff0c\u6b27\u76df\u5219\u79f0\u4e4b\u4e3a\u201cOn-Going\u201d\u3002 \u8fd9\u5c31\u662f\u201cCPV-Continued Process Verification\u201d\u6216\u201cOPV-On-going Process Verification\u201d\u7684\u7531\u6765\u3002 \u56e0\u6b64\u6240\u8c13\u201cProcess Qualification\u5de5\u827a\u786e\u8ba4\u201d\u5b9e\u9645\u5c31\u662f\u5de5\u827a\u7684\u521d\u59cb\u9a8c\u8bc1\u3002<\/span><\/h3>\n


<\/h3>\n

\u53e6\u5916\u8bb2\u5230CPV\uff08\u5de5\u827a\u9a8c\u8bc1\u72b6\u6001\u7684\u6301\u7eed\u786e\u8bc1\uff09\u5c31\u5fc5\u7136\u4f1a\u8054\u7cfb\u5230\u201c\u518d\u786e\u8ba4\u201d\u548c\u201c\u518d\u9a8c\u8bc1\u201d\u3002\u90a3\u4e48CPV\u662f\u5426\u53ef\u4ee5\u4ee3\u66ff\u201c\u518d\u786e\u8ba4\u201d\u548c\u201c\u518d\u9a8c\u8bc1\u201d\uff1f\u7531\u4e8e\u7bc7\u5e45\u7684\u539f\u56e0\uff0c\u8fd9\u4e2a\u95ee\u9898\u7559\u5f85\u4ee5\u540e\u8be6\u7ec6\u8ba8\u8bba\u3002<\/span><\/h3>\n
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Bonus\u2014\u610f\u5916\u6536\u83b7<\/section>\n<\/section>\n<\/section>\n

\u9a8c\u8bc1\u662f\u4e2a\u975e\u5e38\u5e7f\u6cdb\u7684\u6982\u5ff5\u3002\u5de5\u827a\u9a8c\u8bc1\u53ea\u662f\u5176\u4e2d\u7684\u4e00\u79cd\u9a8c\u8bc1\u3002\u5176\u5b83\u7684\u8fd8\u6709\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u7684\u9a8c\u8bc1\uff0c\u5206\u6790\u6d4b\u8bd5\u65b9\u6cd5\u7684\u9a8c\u8bc1\uff0c\u6e05\u6d01\u9a8c\u8bc1\uff0c\u6d88\u6bd2\u706d\u83cc\u9a8c\u8bc1\u7b49\u7b49\u3002\u4ea7\u751f\u5bf9\u9a8c\u8bc1\u548c\u786e\u8ba4\u7684\u6df7\u6dc6\u7684\u53e6\u4e00\u539f\u56e0\u53ef\u80fd\u662f\u7531\u4e8e\u8bb8\u591a\u540c\u4e8b\u6ca1\u6709\u4ed4\u7ec6\u533a\u5206 \u201c\u9a8c\u8bc1\u201d \u548c\u201c\u5de5\u827a\u9a8c\u8bc1\u201d\u3002\u9a8c\u8bc1\u53ef\u4ee5\u901a\u8fc7\u4e0b\u56fe\u6765\u6982\u62ec\u3002<\/span><\/h3>\n

\"\u8d28\u91cf\u4eba\u5fc5\u8bfb|Qualification<\/p>\n

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\u7ed3\u8bed<\/section>\n<\/section>\n<\/section>\n

\u4e60\u6b66\u8005\uff0c\u5200\u67aa\u5251\u621f\uff0c\u5404\u6709\u7ae0\u6cd5\u3002\u771f\u6b63\u6b66\u6797\u9ad8\u624b\u4e0d\u4f1a\u5728\u4e4e\u624b\u4e2d\u662f\u201c\u5200\u201d\u8fd8\u662f\u201c\u5251\u201d\uff0c\u4e5f\u4e0d\u5c51\u8bba\u5176\u5f02\u540c\u3002\u4f46\u5bf9\u5165\u95e8\u8005\u6765\u8bb2\uff0c\u5200\u4e0d\u53ef\u80fd\u7b49\u540c\u4e8e\u5251\uff0c\u7406\u89e3\u5176\u4e2d\u533a\u522b\u5fc5\u7136\u6709\u5229\u4e8e\u66f4\u597d\u5730\u9886\u4f1a\u5176\u8981\u9886\uff0c\u638c\u63e1\u5176\u7cbe\u9ad3\uff0c\u4e92\u4e3a\u501f\u9274\uff0c\u8fdb\u800c\u767b\u5cf0\u9020\u6781\u3002<\/span><\/h3>\n


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\u540c\u7406\uff0c\u5bf9\u4e8e\u521d\u6d89GMP\u7684\u540c\u4e8b\uff0c\u7406\u89e3Qualification \u548cValidation\u7684\u533a\u522b\u6709\u5229\u4e8e\u5c3d\u5feb\u638c\u63e1\u5176\u8981\u9886\uff0c\u51cf\u5c11\u5de5\u4f5c\u4e2d\u7684\u56f0\u60d1\uff0c\u4ece\u800c\u5728\u5de5\u4f5c\u4e2d\u6b63\u786e\u5730\u4f7f\u7528\u8fd9\u4e24\u4e2a\u91cd\u8981\u7684\u6982\u5ff5\u3002\u800c\u5bf9\u4e8e\u8d44\u6df1\u884c\u5bb6\u6765\u8bf4\uff0c\u5bf9 Qualification\u548cValidation\u7684\u7406\u89e3\u548c\u5e94\u7528\u65e9\u5df2\u7ecf\u5f97\u5fc3\u5e94\u624b\uff0c\u5219\u5927\u53ef\u4e0d\u5fc5\u63a2\u7a76\u5176\u5f02\u540c\u3002<\/span><\/h3>\n


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\u603b\u800c\u8a00\u4e4b\uff0cQualification\u548cValidation\u90fd\u662f\u5de5\u827a\u9a8c\u8bc1\u4e2d\u4e0d\u53ef\u7f3a\u5c11\u7684\u90e8\u5206\u3002\u7a76\u5176\u533a\u522b\u4e0d\u662f\u76ee\u7684\uff0c\u7406\u89e3\u5404\u81ea\u5728GMP\u5de5\u4f5c\u4e2d\u7684\u5e94\u7528\u548c\u6240\u8d77\u7684\u4f5c\u7528\uff0c\u6b63\u786e\u5e94\u7528\uff0c\u4ece\u800c\u4fdd\u8bc1\u5de5\u827a\u7684\u6301\u7eed\u7a33\u5b9a\u8fd0\u884c\uff0c\u59cb\u7ec8\u4ea7\u51fa\u5408\u683c\u7684\u4ea7\u54c1\uff0c\u6b64\u4e43\u771f\u6b63\u5927\u9053\u4e5f\uff08\u6b64\u5904\u4e0d\u53ef\u7528\u201c\u8def\u201d\uff09\u3002<\/span><\/h3>\n

\u53c2\u8003\u6587\u732e\uff1a<\/span><\/h3>\n

\u2460\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010 \u5e74\u4fee\u8ba2\uff09\u300b2011<\/span><\/h3>\n

\u2461EU GMP, Annex 15: Qualification and Validation, 2015 http:\/\/ec.europa.eu\/health\/files\/eudralex\/vol-4\/2015-10_annex15.pdf<\/span><\/h3>\n

\u2462Guidance for Industry, Process Validation: General Principles and Practices, FDA 2011 http:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm070336.pdf<\/span><\/h3>\n

\u2463CFR21.820\uff0c Quality System Regulation for medical devices, 2008 http:\/\/www.accessdata.fda.gov\/s\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=820&showFR=1<\/span><\/h3>\n

\u2464\u5173\u4e8eContinued Process Verification\uff08CPV\uff09\u7684\u82f1\u8bed\u7ffb\u8bd1\u7684\u601d\u8003<\/span><\/h3>\n

https:\/\/www.meipian.cn\/81ql3l<\/span><\/h3>\n

\u2465WHO Technical Report Series, No. 937, 2006\uff0c Annex4\uff0c guidance on validation<\/span><\/h3>\n

http:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/SupplementaryGMPValidationTRS937Annex4.pdf<\/span><\/h3>\n

\u2466Paula Katz and Cliff Campbell\uff1a”FDA 2011 Process Validation Guidance: Process Validation Revisited”\uff0c Journal of GXP Compliance \uff0cAutumn 2012 Volume 16 Number 4<\/span><\/h3>\n

\u2467\u7f8e\u56fdFDA \u8b66\u544a\u4fe1\uff1a320-17-33<\/span><\/h3>\n

https:\/\/www.fda.gov\/iceci\/enforcementactions\/warningletters\/2017\/ucm554461.htm<\/span><\/h3>\n

\u2468\u82f1\u6587\u7684\u8bcd\u8bed\u89e3\u91ca\u6765\u81ea”Longman Advanced American Dictionary”, Longman, 2005<\/span><\/h3>\n

\u57f9\u8bad\u63a8\u8350<\/span><\/strong><\/span><\/p>\n

\u836f\u4f01\u516c\u7528\u5de5\u7a0b\u8bbe\u8ba1\u3001\u9a8c\u8bc1\u53ca\u65e5\u5e38\u7ba1\u7406\u7ef4\u62a4\uff08\u6b66\u6c49\uff09\u6280\u672f\u4ea4\u6d41\u4f1a<\/span><\/strong><\/span><\/a>
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\u836f\u4f01\u5982\u4f55\u5f00\u5c55\u4e34\u5e8a\u524d\u5b89\u5168\u6027\u7814\u7a76\u4e13\u9898\u57f9\u8bad\u73ed\uff08ICH S\u6307\u5bfc\uff09<\/span><\/strong><\/span><\/a><\/p>\n

\u201c\u8d28\u91cf\u5de5\u7a0b\u5e08\uff08QA)\u7684\u81ea\u6211\u4fee\u517b\u4e0e\u63d0\u5347\u201d\uff08\u6c88\u9633\uff09\u6280\u672f\u4ea4\u6d41\u4f1a<\/a><\/span><\/strong><\/span><\/p>\n

\u8bc6\u522b\u5fae\u4fe1\u4e8c\u7ef4\u7801\uff0c\u6dfb\u52a0\u5c0f\u7f16\uff0c\u7b26\u5408\u6761\u4ef6\u8005\u5373\u53ef\u52a0\u5165\u751f\u7269\u5236\u54c1\u5fae\u4fe1\u7fa4\uff01<\/strong><\/p>\n


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\u8bf7\u6ce8\u660e\uff1a\u59d3\u540d+\u7814\u7a76\u65b9\u5411\uff01<\/strong><\/span><\/p>\n

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\"\u8d28\u91cf\u4eba\u5fc5\u8bfb|Qualification<\/p>\n

\"\u8d28\u91cf\u4eba\u5fc5\u8bfb|Qualification
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\u672c\u516c\u4f17\u53f7\u6240\u6709\u8f6c\u8f7d\u6587\u7ae0\u7cfb\u51fa\u4e8e\u4f20\u9012\u66f4\u591a\u4fe1\u606f\u4e4b\u76ee\u7684\uff0c\u4e14\u660e\u786e\u6ce8\u660e\u6765\u6e90\u548c\u4f5c\u8005\uff0c\u4e0d\u5e0c\u671b\u88ab\u8f6c\u8f7d\u7684\u5a92\u4f53\u6216\u4e2a\u4eba\u53ef\u4e0e\u6211\u4eec\u8054\u7cfb(cbplib@163.com)\uff0c\u6211\u4eec\u5c06\u7acb\u5373\u8fdb\u884c\u5220\u9664\u5904\u7406\u3002\u6240\u6709\u6587\u7ae0\u4ec5\u4ee3\u8868\u4f5c\u8005\u89c2\u70b9\uff0c\u4e0d\u4ee3\u8868\u672c\u7ad9\u7acb\u573a\u3002<\/span>
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\"\u8d28\u91cf\u4eba\u5fc5\u8bfb|Qualification<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

\u6458\u8981 Qualification\u548cValidation\u662f\u6709\u533a\u522b\u7684\u3002 Qualification\u603b\u662f\u5bf9\u4e8e\u5177\u4f53\u7684\u5b9e […]<\/p>\n","protected":false},"author":1,"featured_media":105226,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/105225"}],"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=105225"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/105225\/revisions"}],"predecessor-version":[{"id":105237,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/105225\/revisions\/105237"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/105226"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=105225"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=105225"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=105225"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}