{"id":19673,"date":"2018-07-30T01:00:00","date_gmt":"2018-08-08T01:13:51","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/08\/08\/%e6%b5%85%e8%b0%88%e9%aa%8c%e8%af%81%e5%91%a8%e6%9c%9f%ef%bc%881%ef%bc%89\/"},"modified":"2018-08-08T09:13:53","modified_gmt":"2018-08-08T01:13:53","slug":"%e6%b5%85%e8%b0%88%e9%aa%8c%e8%af%81%e5%91%a8%e6%9c%9f%ef%bc%881%ef%bc%89","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/19673\/","title":{"rendered":"\u6d45\u8c08\u9a8c\u8bc1\u5468\u671f\uff081\uff09"},"content":{"rendered":"
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\u9a8c\u8bc1\u662f\u8001\u751f\u5e38\u8c08\u7684\u4e00\u4e2a\u8bdd\u9898\uff0c\u5bf9\u4e8e\u5df2\u7ecf\u9a8c\u8bc1\u8fc7\u7684\u7cfb\u7edf\uff0c\u5206\u6790\u65b9\u6cd5\uff0c\u5de5\u827a\u662f\u5426\u9700\u8981\u518d\u9a8c\u8bc1\uff0c\u591a\u957f\u65f6\u95f4\u9a8c\u8bc1\u6216\u57fa\u4e8e\u4ec0\u4e48\u60c5\u51b5\u4e0b\u518d\u9a8c\u8bc1\uff1f\u672c\u6587\u9488\u5bf9\u516c\u5171\u7cfb\u7edf\uff0c\u8ba1\u7b97\u673a\u7cfb\u7edf\u548c\u5206\u6790\u65b9\u6cd5\u603b\u7ed3\u4e86\u5404\u6cd5\u89c4\u7684\u9488\u5bf9\u518d\u9a8c\u8bc1\u63d0\u51fa\u7684\u76f8\u5173\u5efa\u8bae\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


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\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u65b9\u5f0f\u7684\u5e94\u7528\u8d2f\u7a7f\u836f\u54c1\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u3002\u4f5c\u4e3a\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u7cfb\u7edf\u7684\u4e00\u90e8\u5206\uff0c\u9a8c\u8bc1\u53ca\u786e\u8ba4\u8303\u56f4\u548c\u7a0b\u5ea6\u7684\u51b3\u5b9a\u5e94\u57fa\u4e8e\u7ecf\u8fc7\u8bc1\u660e\u7684\u3001\u6587\u4ef6\u8bb0\u5f55\u7684\u8bbe\u65bd\u3001\u8bbe\u5907\u3001\u516c\u7528\u5de5\u7a0b\u4e8e\u5de5\u827a\u7684\u98ce\u9669\u8bc4\u4f30\u3002\u65e2\u7136\u9a8c\u8bc1\u7b97\u662f\u98ce\u9669\u7ba1\u7406\u7684\u4e00\u90e8\u5206\u5e76\u4e14\u5e94\u8be5\u8d2f\u7a7f\u836f\u54c1\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\uff0c\u90a3\u4e48\u54ea\u4e9b\u90e8\u5206\u9700\u8981\u9a8c\u8bc1\u5462\uff1f<\/span>
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\u57fa\u4e8e<\/span>WHO\u7684\u8981\u6c42\uff0c\u9a8c\u8bc1\u5305\u62ec\u516c\u5171\u7cfb\u7edf\u9a8c\u8bc1\uff08\u6c34\u7cfb\u7edf\u3001HVAC\u7cfb\u7edf\uff09\uff0c\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u3001\u6e05\u6d01\u9a8c\u8bc1\u3001\u5de5\u827a\u9a8c\u8bc1\u3001\u8ba1\u7b97\u673a\u7cfb\u7edf\u9a8c\u8bc1\u4ee5\u53ca\u8bbe\u5907\u7684\u786e\u8ba4\u3002\u800c\u6b27\u76dfGMP\u9488\u5bf9\u5305\u88c5\u548c\u8fd0\u8f93\u4e5f\u63d0\u51fa\u4e86\u9700\u8981\u9a8c\u8bc1\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u6709\u4eba\u4f1a\u95ee\uff0c\u9a8c\u8bc1\u548c\u786e\u8ba4\u5230\u5e95\u6709\u4ec0\u4e48\u5173\u7cfb\u6216\u8005\u6709\u4f55\u533a\u522b\u5462\uff1f\u5176\u5b9e\u9a8c\u8bc1\u548c\u786e\u8ba4\u672c\u8d28\u4e0a\u662f\u4e00\u4e2a\u6982\u5ff5\uff0c\u786e\u8ba4\u4e00\u822c\u9488\u5bf9\u8bbe\u5907\uff0c\u4eea\u5668\u548c\u7cfb\u7edf\u800c\u8a00\uff0c\u800c\u9a8c\u8bc1\u4e00\u822c\u9488\u5bf9\u5de5\u827a\u6216\u751f\u4ea7\u8fc7\u7a0b\u3002\u5c31\u5b57\u9762\u7684\u89e3\u91ca\u6765\u770b\uff0c\u786e\u8ba4\u662f\u9a8c\u8bc1\u7684\u4e00\u90e8\u5206\uff0c\u5e76\u4e14\u786e\u8ba4\u5e94\u8be5\u5728\u9a8c\u8bc1\u5b9e\u65bd\u524d\u5b8c\u6210\u3002\u6b63\u5982<\/span>WHO\u6307\u5357\u4e2d\u6240\u8ff0\uff1a<\/span>Relationship between validation and qualification<\/span> <\/span>Validation and qualification are essentially components of the same concept. The term qualification is normally used for equipment, utilities and systems, and validation for processes. In this sense, qualification is part of validation.<\/span><\/em> <\/span><\/p>\n

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WHO\u6307\u5357\u8ba4\u4e3a\u5e94\u9488\u5bf9\u65b0\u5382\u623f\uff0c\u8bbe\u5907\uff0c\u8bbe\u65bd\u548c\u7cfb\u7edf\uff0c\u4ee5\u53ca\u65b0\u5efa\u7acb\u7684\u5de5\u827a\u548c\u89c4\u7a0b\uff0c\u6216\u8005\u51fa\u73b0\u91cd\u5927\u53d8\u66f4\u65f6\u5e94\u8fdb\u884c\u9a8c\u8bc1\u3002\u90a3\u4e48\u5df2\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u516c\u5171\u8bbe\u65bd\uff0c\u7cfb\u7edf\uff0c\u5206\u6790\u65b9\u6cd5\uff0c\u5de5\u827a\u7b49\uff0c\u662f\u5426\u8fd8\u9700\u8981\u518d\u9a8c\u8bc1\uff1f\u591a\u957f\u65f6\u95f4\u9a8c\u8bc1\uff1f\u4f55\u79cd\u60c5\u51b5\u4e0b\u9a8c\u8bc1\uff1f\u672c\u6587\u9488\u5bf9\u4e0a\u8ff0\u95ee\u9898\uff0c\u603b\u7ed3\u4e86\u5404\u6cd5\u89c4\u4e2d\u9488\u5bf9HVAC, \u6c34\u7cfb\u7edf\uff0c\u8ba1\u7b97\u673a\u7cfb\u7edf\u4ee5\u53ca\u5206\u6790\u65b9\u6cd5\u5efa\u8bae\u7684\u9a8c\u8bc1\u5468\u671f\u4ee5\u53ca\u9700\u8981\u518d\u9a8c\u8bc1\u7684\u60c5\u51b5\u3002<\/span><\/p>\n


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\u9488\u5bf9<\/span>HVAC\u7cfb\u7edf\uff0cWHO\u57282011\u5e74\u51fa\u53f0\u4e86TRS961\u6587\u4ef6\u7528\u6765\u4ee3\u66ff\u539f\u6765\u53d1\u5e03\u7684TRS937\u6587\u4ef6\uff0c\u5728TRS937\u6587\u4ef6\u4e2d\uff0c WHO\u5efa\u8bae\u5bf9HVAC\u7cfb\u7edf\u6bcf\u5e74\u8fdb\u884c\u9a8c\u8bc1\uff0c\u9a8c\u8bc1\u7684\u5185\u5bb9\u5305\u62ec\u6e29\u5ea6\uff0c\u76f8\u5bf9\u6e7f\u5ea6\uff0c\u9001\u98ce\u91cf\uff0c\u56de\u98ce\u91cf\u6216\u6392\u6c14\u91cf\uff0c\u6362\u6c14\u901f\u5ea6\uff0c\u538b\u5dee\uff0c\u5355\u5411\u6d41\u901f\u5ea6\uff0c\u7c92\u5b50\u8ba1\u6570\u7b49\u6307\u6807\uff0c\u800c\u5bf9\u4e8e\u623f\u95f4\u7c92\u5b50\u8ba1\u6570\uff0c\u5efa\u8bae\u6bcf\u534a\u5e74\u9a8c\u8bc1\u4e00\u6b21\u3002\u800cTRS961\u6587\u4ef6\u4e2d\u5efa\u8bae\u7684\u9a8c\u8bc1\u5468\u671f\u5220\u9664\u4e86\uff0c\u8868\u660e\u6d4b\u8bd5\u5468\u671f\u5e94\u8be5\u57fa\u4e8e\u5728\u98ce\u9669\u8bc4\u4f30\u7684\u57fa\u7840\u4e0a\u7531\u751f\u4ea7\u5546\u5b9a\u593a\uff0c\u5e76\u4e14\u5efa\u8bae\u5f53\u5f71\u54cd\u5230\u8be5\u7cfb\u7edf\u6027\u80fd\u7684\u53d8\u66f4\u51fa\u73b0\u65f6\u5e94\u8be5\u8fdb\u884c\u518d\u9a8c\u8bc1\u3002<\/span><\/p>\n

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WHO\u4e8e 2018\u5e74\u6700\u65b0\u53d1\u5e03\u7684TRS 1010\u6587\u4ef6\u4e2d\u5efa\u8bae\u5e94\u57fa\u4e8e\u98ce\u9669\uff0c\u8bbe\u65bd\u7c7b\u578b\uff0c\u4ea7\u54c1\uff0c\u4ee5\u53ca\u53d8\u66f4\u7684\u8303\u56f4\u548c\u5f71\u54cd\u7b49\u65b9\u9762\u8003\u8651\u518d\u9a8c\u8bc1\u7684\u5b9e\u65bd\uff0c\u8be5\u6587\u4ef6\u8fd8\u672a\u53d6\u4ee3TRS961\u6587\u4ef6\uff0c\u5c0f\u7f16\u8ba4\u4e3a\u539f\u6765\u5efa\u8bae\u7684\u9a8c\u8bc1\u5468\u671f\u8fd8\u662f\u6709\u4e00\u5b9a\u53c2\u8003\u4ef7\u503c\u7684\u3002<\/span><\/p>\n

\u65b0\u65e7\u6587\u4ef6\u5bf9\u6bd4\uff1a<\/span><\/span>
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\"\u6d45\u8c08\u9a8c\u8bc1\u5468\u671f\uff081\uff09\"<\/p>\n

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WHO\u51fa\u53f0\u7684TRS970 \u9488\u5bf9WPU\u9a8c\u8bc1\u8981\u6c42\uff0c\u5c06\u5236\u836f\u7528\u6c34\u5206\u4e3aBPW, BHPW\u548cBWFI\u7b49\u4e0d\u540c\u7c7b\u522b\u7684\u6c34\u8d28\uff0c\u5e76\u4e14\u8f83\u6700\u5f00\u59cb\u7684\u6587\u4ef6\u6536\u7a84\u4e86\u5bf9\u6c34\u7cfb\u7edf\u7684\u9a8c\u8bc1\u5468\u671f\uff0c\u8981\u6c42\u5728\u7b2c\u4e00\u9636\u6bb5\u65f6\uff0c\u6bcf\u5929\u8fde\u7eed\u5bf9\u996e\u7528\u6c34\u8fde\u7eed\u91c7\u6837\u6301\u7eed2\u5468\u4ee5\u76d1\u6d4b\u5176\u6c34\u8d28\u3002\u7b2c\u4e8c\u9636\u6bb5\u5728\u7b2c\u4e00\u9636\u6bb5\u5f97\u5230\u6ee1\u610f\u7ed3\u679c\u7684\u6761\u4ef6\u4e0b\uff0c\u7ee7\u7eed\u91c7\u68372\u5468\uff0c\u5982\u679c\u68c0\u6d4b\u7ed3\u679c\u4ecd\u80fd\u8fbe\u5230\u65e2\u5b9a\u6807\u51c6\uff0c\u5219\u8be5\u6c34\u53ef\u4ee5\u7528\u4f5cFPP\u7684\u751f\u4ea7\u3002\u7b2c\u4e09\u9636\u6bb5\u662f\u57fa\u4e8e\u7b2c\u4e8c\u9636\u6bb5\u68c0\u6d4b\u7ed3\u679c\u6ee1\u610f\u7684\u6761\u4ef6\u4e0b\uff0c\u6c34\u7cfb\u7edf\u8fd0\u884c\u4e00\u5e74\u518d\u68c0\u6d4b\u3002\u5728\u7b2c\u4e09\u9636\u6bb5\u68c0\u6d4b\u7ed3\u679c\u4ecd\u6ee1\u610f\u7684\u6761\u4ef6\u4e0b\uff0cWHO\u5efa\u8bae\u5bf9\u6c34\u7cfb\u7edf\u5e94\u91c7\u53d6\u7cfb\u7edf\u6027\u56de\u987e\uff0c\u5305\u62ec\u5982\u5bf9\u6c34\u673a\u4ea7\u6c34\uff0c\u603b\u9001\u6c34\u70b9\uff0c\u603b\u56de\u6c34\u70b9\uff0c\u7528\u6c34\u70b9\u6c34\u8d28\u8fdb\u884c\u8d8b\u52bf\u5206\u6790\uff0c\u5e76\u5236\u5b9a\u8b66\u6212\u9650\u548c\u884c\u52a8\u9650\uff0c\u5982\u679c\u51fa\u73b0\u8d8b\u52bf\u53d8\u5dee\u6216\u6c34\u8d28\u4e0d\u5408\u683c\uff0c\u5e94\u67e5\u627e\u539f\u56e0\u5e76\u91c7\u53d6\u76f8\u5e94\u7684\u63aa\u65bd\uff0c\u540c\u65f6\u8bc4\u4f30\u662f\u5426\u9700\u8981\u518d\u9a8c\u8bc1\u3002\u5728\u8fd9\u4e2a\u6301\u7eed\u7cfb\u7edf\u76d1\u6d4b\u7684\u8fc7\u7a0b\u4e2d\u5e94\u8be5\u4f7f\u7528\u5728\u7ebf\u76d1\u6d4b\u8bbe\u5907\uff0c\u4ee5\u5bf9\u68c0\u6d4b\u6d41\u91cf\uff08\u80fd\u63a8\u6d4b\u51fa\u672b\u7aef\u6d41\u901f\uff09\uff0c\u538b\u529b\uff0c\u6e29\u5ea6\uff0c\u7535\u5bfc\u7387\uff0cTOC\u7b49\u53c2\u6570\u8fdb\u884c\u76d1\u6d4b\u3002<\/span><\/p>\n


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\u5f53\u8ba1\u7b97\u673a\u7cfb\u7edf\u6709\u53d8\u66f4\u65f6\uff0c<\/span>OMCL \u5efa\u8bae\u5bf9\u4e8e\u8be5\u7cfb\u7edf\u8f6f\u4ef6\u8fdb\u884c\u8bc4\u4f30\u4ee5\u786e\u5b9a\u662f\u5426\u9700\u8981\u518d\u9a8c\u8bc1\uff0c\u540c\u65f6\u8981\u8003\u8651\u5230\u518d\u9a8c\u8bc1\u7684\u8303\u56f4\uff0c\u56e0\u4e3a\u8be5\u53d8\u66f4\u53ef\u80fd\u4e0d\u4ec5\u4ec5\u5f71\u54cd\u7684\u662f\u5355\u4e00\u7684\u8ba1\u7b97\u673a\uff0c\u4e5f\u53ef\u80fd\u5f71\u54cd\u5230\u6574\u4e2a\u8ba1\u7b97\u673a\u63a7\u5236\u7cfb\u7edf\u3002\u540c\u6837\uff0c\u5982\u679c\u8ba1\u7b97\u673a\u73af\u5883\u53d1\u751f\u53d8\u5316\u5e76\u5bf9\u8f6f\u4ef6\u7684\u8fd0\u884c\u9020\u6210\u5f71\u54cd\u65f6\uff0c\u8ba1\u7b97\u673a\u7cfb\u7edf\u8f6f\u4ef6\u5efa\u8bae\u88ab\u518d\u9a8c\u8bc1\u3002<\/span><\/p>\n

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\u5bf9\u4e8e\u4e13\u4e1a\u7248<\/span>\/\u5b9a\u5236\u7248\u8ba1\u7b97\u673a\u7cfb\u7edf\uff0cOMCL\u5efa\u8bae\u5bf9\u8f6f\u786c\u4ef6\u914d\u7f6e\u6bcf6\u4e2a\u6708\u8fdb\u884c\u5b9a\u671f\u56de\u987e\u6216\u8005\u5728\u53d8\u66f4\u5b8c\u6210\u540e\u8fdb\u884c\u56de\u987e\u3002WHO\u57282018\u5e745\u6708\u51fa\u53f0\u4e86\u9488\u5bf9\u8ba1\u7b97\u673a\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u7684\u5f81\u6c42\u610f\u89c1\u7a3f\u3002\u6587\u4ef6\u4e2d\u672a\u5bf9\u8ba1\u7b97\u673a\u7cfb\u7edf\u6709\u660e\u786e\u7684\u5bf9\u4e8e\u5468\u671f\u6027\u9a8c\u8bc1\u7684\u5efa\u8bae\u3002\u5b83\u5efa\u8bae\u5468\u671f\u6027\u56de\u987e\u8ba1\u7b97\u673a\u7cfb\u7edf\u5e76\u4e14\u6839\u636e\u56de\u987e\u7ed3\u679c\u8bc4\u4f30\u662f\u5426\u9700\u8981\u518d\u9a8c\u8bc1\uff0c\u5e76\u4e14\u518d\u9a8c\u8bc1\u7684\u8303\u56f4\u548c\u5185\u5bb9\u5e94\u8be5\u57fa\u4e8e\u98ce\u9669\u8bc4\u4f30\u3002<\/span><\/p>\n


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\u5bf9\u4e8e\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\uff0c<\/span>WHO\u548cICH\u5efa\u8bae\u51fa\u73b0\u4ee5\u4e0b\u60c5\u51b5\u65f6\u8fdb\u884c\u786e\u8ba4\u6216\u518d\u9a8c\u8bc1\uff0c\u5982\u5f53\u539f\u6599\u836f\u5408\u6210\u8def\u7ebf\u53d1\u751f\u53d8\u5316\u65f6\uff08\u53ef\u80fd\u5f15\u5165\u65b0\u7684\u6742\u8d28\uff0c\u526f\u4ea7\u7269\u6216\u964d\u89e3\u4ea7\u7269\uff0c\u6216\u662f\u5f15\u5165\u65b0\u7684\u6eb6\u5242\uff09\uff0c\u5236\u5242\u7684\u7ec4\u6210\u53d1\u751f\u53d8\u5316\u65f6\uff0c\u4f7f\u7528\u7684\u5206\u6790\u65b9\u6cd5\u53d1\u751f\u53d8\u5316\u65f6\uff0c\u6216\u4f7f\u7528\u7684\u5206\u6790\u65b9\u6cd5\u4ece\u4e00\u4e2a\u5b9e\u9a8c\u5ba4\u8f6c\u79fb\u5230\u53e6\u4e00\u4e2a\u5b9e\u9a8c\u5ba4\u65f6\uff0c\u6216\u4e3b\u8981\u8bbe\u5907\u53d1\u751f\u53d8\u5316\u65f6\u7b49\uff0c\u9700\u8981\u5bf9\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u786e\u8ba4\u6216\u518d\u9a8c\u8bc1\u3002FDA\u9488\u5bf9\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u5efa\u8bae\u5b9a\u671f\u5bf9\u65b9\u6cd5\u8fdb\u884c\u8d8b\u52bf\u5206\u6790\u4ee5\u8bc4\u4f30\u662f\u5426\u9700\u8981\u4f18\u5316\u65b9\u6cd5\u6216\u8005\u5bf9\u6574\u4e2a\u65b9\u6cd5\u6216\u90e8\u5206\u65b9\u6cd5\u8fdb\u884c\u518d\u9a8c\u8bc1\u3002\u5f53\u5206\u6790\u65b9\u6cd5\u53d8\u5316\u65f6\uff0c\u6216\u8005\u4f7f\u7528\u4e00\u4e2a\u65b0\u7684\u5206\u6790\u65b9\u6cd5\uff0c\u6216\u8005\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u65f6\uff0c\u8981\u8003\u8651\u8fdb\u884c\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u3002<\/span><\/p>\n

 <\/span><\/p>\n

FDA\u6307\u51fa\u5982\u679c\u5206\u6790\u65b9\u6cd5\u53ea\u80fd\u6ee1\u8db3\u7cfb\u7edf\u9002\u7528\u6027\u6761\u4ef6\u800c\u5728\u64cd\u4f5c\u65f6\u6309\u7167\u5206\u6790\u65b9\u6cd5\u7684\u64cd\u4f5c\u6761\u4ef6\u8981\u8fdb\u884c\u53cd\u590d\u7684\u8c03\u8bd5\uff0c\u90a3\u4e48\u8fd9\u4e2a\u5206\u6790\u65b9\u6cd5\u5efa\u8bae\u88ab\u91cd\u65b0\u8bc4\u4ef7\uff0c\u9a8c\u8bc1\u6216\u4fee\u6b63\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4ece\u4ee5\u4e0a\u5206\u6790\u6765\u770b\uff0c\u5bf9\u8bbe\u65bd\u8bbe\u5907\u3001\u6e05\u6d01\u65b9\u6cd5\u7b49\u7ecf\u8fc7\u786e\u8ba4\u6216\u9a8c\u8bc1\u8fc7\u7684\u98ce\u9669\u63a7\u5236\u72b6\u6001\u7684\u8fdb\u884c\u5b9a\u671f\u8bc4\u4f30\u662f\u975e\u5e38\u6709\u5fc5\u8981\u7684\uff0c\u8fd9\u79cd\u5b9a\u671f\u8bc4\u4f30\u53ef\u4ee5\u786e\u4fdd\u5176\u98ce\u9669\u63a7\u5236\u5904\u4e8e\u6709\u6548\u7684\u72b6\u6001\uff0c\u4ece\u800c\u786e\u4fdd\u98ce\u9669\u80fd\u591f\u5728\u751f\u547d\u5468\u671f\u5185\u5f97\u5230\u63a7\u5236\u3002\u7ecf\u8fc7\u6700\u521d\u7684\u5173\u952e\u6027\u8bc4\u4f30\u548c\u5b9a\u671f\u7684\u8bc4\u4f30\u540e\uff0c\u5fc5\u8981\u60c5\u51b5\u4e0b\u9700\u8981\u5bf9\u5173\u952e\u7684\u5de5\u827a\u548c\u64cd\u4f5c\u8fdb\u884c\u5b9a\u671f\u518d\u9a8c\u8bc1\u6216\u518d\u786e\u8ba4\u3002<\/span><\/span><\/p>\n


<\/span><\/span><\/p>\n

\u6ce8\uff1a\u7531\u4e8e\u5c0f\u7f16\u4e5f\u52aa\u529b\u8ffd\u9010\u6cd5\u89c4\u4e0d\u65ad\u53d8\u5316\u7684\u811a\u6b65\uff0c\u6240\u4ee5\u5982\u679c\u6cd5\u89c4\u6ca1\u6709\u53ca\u65f6\u66f4\u65b0\u5230\u6216\u89e3\u8bfb\u4e0d\u5168\u9762\uff0c\u5c3d\u8bf7\u8c05\u89e3\u3002<\/span><\/span><\/em><\/strong><\/p>\n


<\/span><\/span><\/strong><\/p>\n

\u53c2\u8003\u6587\u732e<\/span><\/span><\/strong><\/p>\n

\u3010<\/span>1\u3011\u6b27\u76df<\/span>GMP\/GDP<\/span>\uff0c<\/span><\/span>annex 15 \u2013 qualification and validation (revision 1):general: a quality risk management approach should be applied throughout the lifecycle of a medicinal product. As part of a quality risk management system, decisions on the scope and extent of validation and qualification should be based on a justified and documented risk assessment of the facilities, equipment, utilities and processes.<\/span><\/p>\n

\u3010<\/span>2\u3011<\/span>WHO<\/span>\uff1a<\/span><\/span>Annex 2- Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms, TRS937, 2006.<\/span><\/p>\n

\u30103\u3011<\/span>WHO\uff1a <\/span>Annex 5- Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms, TRS961, 2011.<\/span><\/p>\n

\u3010<\/span>4\u3011<\/span>WHO\uff1a<\/span><\/span>expert committee on specifications for pharmaceutical preparations, TRS1010.<\/span><\/p>\n

\u3010<\/span>5\u3011<\/span>WHO<\/span>\uff1a<\/span><\/span>Annex 2 WHO good manufacturing practices: water for pharmaceutical use<\/span><\/p>\n

\u3010<\/span>6\u3011<\/span>OMCL<\/span>\uff1a<\/span><\/span>Validation of computerized systems core document<\/span><\/p>\n

\u30107\u3011OMCL\uff1aValidation of computerized systems core document \u2013 Annex 1<\/span><\/p>\n

\u30108\u3011WHO\uff1a Annex 4- Supplementary guidelines on good manufacturing practices: validation<\/span><\/p>\n

\u30109\u3011ICH Q2(R1)-Validation of analytical procedures: text and methodology<\/span><\/p>\n

\u301010\u3011FDA\uff1aAnalytical procedures and methods validation for drugs and biologics<\/span><\/p>\n

\u301011\u3011WHO: Guidelines on validation- Appendix 5  Validation of computerized system (May 2018)<\/span><\/p>\n


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\u6392\u7248\uff1a\u9621\u4e0a\u964c\u964c<\/span>
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\u5e7f\u800c\u544a\u4e4b<\/section>\n<\/section>\n<\/section>\n
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\u2299 \u540c\u5199\u610f\u57f9\u8bad<\/span><\/p>\n

\u5199\u610f\u8bba\u575b\u4e28\u65b0\u836f\u4e2d\u7f8e\u53cc\u62a5\u4e4b\u5236\u5242\u6eb6\u51fa\u6280\u672f\u5f00\u53d1<\/a><\/span><\/p>\n

\u5199\u610f\u8bba\u575b\u4e28\u56fd\u9645\u89c4\u8303\u4e0b\u751f\u7269\u836f\u5168\u751f\u547d\u5468\u671f\u8d28\u91cf\u7ba1\u7406<\/a><\/span><\/p>\n

\u5199\u610f\u516c\u76ca\u4e28\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u5927\u76d8\u70b9\u4e0e\u603b\u51b3\u6218<\/a><\/p>\n

\u6ee1\u8db3IND\/NDA\u4e2d\u7f8e\u53cc\u62a5\u7684\u53e3\u670d\u65b0\u836f\u5236\u5242\u7814\u53d1<\/a><\/span><\/p>\n<\/section>\n<\/section>\n


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\"\u6d45\u8c08\u9a8c\u8bc1\u5468\u671f\uff081\uff09\"<\/p>\n

\u836f\u4e8b\u7eb5\u6a2a\u662f\u4e00\u4e2a\u5f00\u653e\uff0c\u7531\u81ea\u613f\u8005\u7ec4\u6210\u7684\u56e2\u4f53\uff0c\u73b0\u6709\u6210\u545838\u540d\uff0c\u5206\u522b\u4e3aVoyager88\uff08\u9b4f\u5229\u519b\uff09\uff0c\u96f7\u8bfa\u5c9b\uff0c\u4e09\u5206\u8bdd\uff0cHerman\uff0c\u6885\u5e0c\uff0c\u6587\u7af9\uff0cduke\uff0cyhqqqqq\uff0c\u5360\u5c0f\u5175\uff0c\u98ce\u4e00\u6837\u7684\u5c4e\u58f3\u90ce\uff0c\u9526\u5fc3\u7ee3\u53e3\uff0cflydp511\uff0c\u5de7\u5de7\uff0c\u4e91\u6c34\u9053\u4eba\uff0c\u9621\u4e0a\u964c\u964c\uff0c\u591a\u5df4\u80fa\uff0c\u745c\u513f\uff0cKailyn\uff0cSmall fish\uff0c\u5b50\u708e\uff0c\u514b\u683c\u83ab\uff0cVicky\uff0cPandada\uff0c\u83ab\u5306\u5306\uff0cSophia \uff0c\u4f9d\u7136\u7279\u96f7\u897f\uff0c\u5076\u9635\u96e8\uff0cAimee\uff0c\u4ed6\u5c71\u4e4b\u77f3\uff0c\u5510\u5c0f\u7396\uff0c\u96f6\u4e0b274\u2103\uff0cGloria\uff0cBreathless\uff0cLuffy\uff0c\u80e1\u4e0d\u559c\uff0c Helen\uff0c\u843d\u843d\uff0cSUNRISE\u3002\u6b22\u8fce\u6709\u5fd7\u4e4b\u58eb\u52a0\u5165\u6211\u4eec\u56e2\u961f\u3002\u6295\u7a3f\u3001\u5408\u4f5c\u3001\u52a0\u4e13\u4e1a\u7fa4\u8bf7\u52a0\u5fae\u4fe1442015666\uff0c\u836f\u4e8b\u7eb5\u6a2a\u4e8c\u5343\u4ebaQQ\u7fa422711855\u3002<\/span><\/p>\n

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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u836f\u4e8b\u7eb5\u6a2a <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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