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\/><\/strong><\/p>\n<p>\u65b9\u6cd5\u8f6c\u79fb\u7684\u6700\u5e38\u89c1\u65b9\u5f0f\u3002\u5b83\u8981\u6c42SU\u548cRU\u5bf9\u540c\u4e00\u6279\u6b21\u7684\u9884\u5b9a\u6570\u91cf\u7684\u6837\u54c1\u8fdb\u884c\u5206\u6790\uff0c\u7136\u540e\u5bf9\u7ed3\u679c\u8fdb\u884c\u6bd4\u8f83\u3002\u68c0\u6d4b\u57fa\u4e8e\u5148\u524d\u6279\u51c6\u7684l\u8f6c\u79fb\u65b9\u6848\uff0c\u5176\u4e2d\u9884\u5b9a\u4e49\u4e86\u9a8c\u6536\u6807\u51c6\u548c\u53ef\u63a5\u53d7\u7684\u6539\u53d8\u8303\u56f4\u3002\u5728\u8f6c\u79fb\u4e4b\u524d\uff0c\u5e94\u5728SU\u4e2d\u9a8c\u8bc1\u5206\u6790\u65b9\u6cd5\u3002\u5e94\u7f16\u5236\u4e00\u4efd\u8f6c\u79fb\u62a5\u544a\uff0c\u786e\u8ba4\u7b26\u5408\u9884\u5b9a\u4e49\u7684\u9a8c\u6536\u6807\u51c6\u3002<\/p>\n<p><strong>2. \u540c\u6b65\u9a8c\u8bc1<br \/><\/strong><\/p>\n<p>\u5982\u679c\u8be5\u65b9\u6cd5\u5c1a\u672a\u5f97\u5230\u9a8c\u8bc1\uff0c\u90a3\u4e48\u540c\u6b65\u9a8c\u8bc1\u4f3c\u4e4e\u662f\u4e00\u4e2a\u5408\u9002\u7684\u9009\u62e9\u3002\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0cSU\u53ef\u4ee5\u8ba9RU\u53c2\u4e0e\u5b9e\u9a8c\u5ba4\u95f4\u540c\u6b65\u9a8c\u8bc1\u3002\u5f53\u65b9\u6cd5\u4ece\u7814\u53d1\u8f6c\u79fb\u5230\u8d28\u91cf\u63a7\u5236\u5b9e\u9a8c\u5ba4\u65f6\uff0c\u901a\u5e38\u4f1a\u9009\u62e9\u8fd9\u79cd\u65b9\u6cd5\u3002\u4e0e\u6bd4\u8f83\u68c0\u6d4b\u7c7b\u4f3c\uff0c\u540c\u6b65\u9a8c\u8bc1\u4e5f\u9700\u8981\u9884\u5148\u6279\u51c6\u7684\u65b9\u6848\u548c\u6700\u7ec8\u62a5\u544a\u3002\u7136\u800c\uff0c\u6839\u636eICH Q2[4]\uff0c\u8f6c\u79fb\u6587\u4ef6\u8fd8\u5c06\u5305\u62ec\u65b9\u6cd5\u9a8c\u8bc1\u8981\u7d20\u3002<\/p>\n<p><strong>3. \u91cd\u65b0\u9a8c\u8bc1 <br \/><\/strong><\/p>\n<p style=\"text-align: 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style=\"height:29px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>SciencePharma<\/strong> 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class=\"has-small-font-size\"><em>[1] WHO guidelines on transfer of technology in pharmaceutical manufacturing, Annex 7 (2011) in Technical Report Series 961<\/em><\/p>\n<p class=\"has-small-font-size\"><em>[2] EU GMP Chapter 6 (Oct. 2014): Quality Control<\/em><\/p>\n<p class=\"has-small-font-size\"><em>[3] USP General Chapter &lt;1224&gt; Transfer of Analytical Procedures<\/em><\/p>\n<p class=\"has-small-font-size\"><em>[4] ICH Q2(R2) Validation of analytical procedures, CPMP\/ICH\/381\/95<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb \u5728\u836f\u54c1\u4e0a\u5e02\u524d\u3001\u6574\u4e2a\u751f\u547d\u5468\u671f\u3001\u5e38\u89c4\u5236\u9020\u8fc7\u7a0b\u4e2d\u4ee5\u53ca\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u5bf9\u836f\u54c1\u8fdb\u884c\u68c0\u6d4b\u662f\u5236\u836f\u884c\u4e1a\u7684\u57fa\u7840\u3002\u8d77\u59cb\u7269\u6599 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