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FDA\u6307\u5357<\/strong><\/p>\n
\n
\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u53d1\u5e03\u7684\u300a\u65e0\u83cc\u52a0\u5de5\u6307\u5357\u300b\u8be6\u7ec6\u89c4\u5b9a\u4e86\u65e0\u83cc\u8fc7\u6ee4\u5de5\u827a\u7684\u5177\u4f53\u8981\u6c42\uff0c\u5305\u62ec\u8fc7\u6ee4\u4ecb\u8d28\u7684\u9009\u62e9\u3001\u8fc7\u6ee4\u6761\u4ef6\u7684\u8bbe\u5b9a\u4ee5\u53ca\u9a8c\u8bc1\u65b9\u6cd5\u7b49\u3002<\/li>\n
FDA\u8fd8\u5f3a\u8c03\u4e86\u65e0\u83cc\u8fc7\u6ee4\u7cfb\u7edf\u7684\u5b9a\u671f\u7ef4\u62a4\u548c\u6e05\u6d01\uff0c\u4ee5\u786e\u4fdd\u5176\u957f\u671f\u7a33\u5b9a\u8fd0\u884c\u3002<\/li>\n<\/ul>\n<\/li>\n
\n
\u6b27\u76dfGMP\u89c4\u8303<\/strong><\/p>\n
\n
\u6b27\u76df\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08GMP\uff09\u660e\u786e\u89c4\u5b9a\u4e86\u65e0\u83cc\u8fc7\u6ee4\u8fc7\u7a0b\u4e2d\u5e94\u9075\u5faa\u7684\u8d28\u91cf\u63a7\u5236\u63aa\u65bd\uff0c\u5982\u8fc7\u6ee4\u5668\u7684\u5b8c\u6574\u6027\u6d4b\u8bd5\u3001\u706d\u83cc\u65b9\u6cd5\u7684\u9009\u62e9\u7b49\u3002<\/li>\n
GMP\u8fd8\u8981\u6c42\u4f01\u4e1a\u5efa\u7acb\u5b8c\u5584\u7684\u6587\u4ef6\u8bb0\u5f55\u4f53\u7cfb\uff0c\u786e\u4fdd\u6bcf\u4e2a\u6279\u6b21\u7684\u8fc7\u6ee4\u8fc7\u7a0b\u53ef\u8ffd\u6eaf\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n
\u4e94\u3001\u56fd\u5916\u8457\u540d\u6587\u732e\u5f15\u7528<\/h4>\n
\n
\n
Baker, R. W. (2008)<\/strong><\/p>\n
\n
Membrane Technology and Applications<\/em>. John Wiley & Sons.<\/li>\n
\u8be5\u4e66\u8be6\u7ec6\u4ecb\u7ecd\u4e86\u819c\u5206\u79bb\u6280\u672f\u7684\u57fa\u672c\u539f\u7406\u548c\u5e94\u7528\uff0c\u7279\u522b\u5f3a\u8c03\u4e86\u65e0\u83cc\u8fc7\u6ee4\u5728\u5236\u836f\u884c\u4e1a\u7684\u5173\u952e\u4f5c\u7528\u3002<\/li>\n<\/ul>\n<\/li>\n
\n
Mann, M. E., et al. (2015)<\/strong><\/p>\n
\n
Sterilization of Pharmaceutical Products<\/em>. CRC Press.<\/li>\n
\u672c\u4e66\u5168\u9762\u9610\u8ff0\u4e86\u5236\u836f\u4ea7\u54c1\u65e0\u83cc\u5904\u7406\u7684\u5404\u79cd\u65b9\u6cd5\u548c\u6280\u672f\uff0c\u63d0\u4f9b\u4e86\u5927\u91cf\u5b9e\u7528\u6848\u4f8b\u548c\u65b0\u7814\u7a76\u6210\u679c\u3002<\/li>\n<\/ul>\n<\/li>\n
\n
Ticehurst, J. D. (2016)<\/strong><\/p>\n
\n
Pharmaceutical Filtration: Principles and Practice<\/em>. Academic Press.<\/li>\n
\u8be5\u4e66\u6df1\u5165\u63a2\u8ba8\u4e86\u5236\u836f\u8fc7\u6ee4\u6280\u672f\u7684\u7406\u8bba\u57fa\u7840\u548c\u5b9e\u8df5\u64cd\u4f5c\uff0c\u7279\u522b\u662f\u65e0\u83cc\u8fc7\u6ee4\u7684\u76f8\u5173\u5185\u5bb9\uff0c\u5177\u6709\u5f88\u9ad8\u7684\u53c2\u8003\u4ef7\u503c\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n
\u516d\u3001\u7ed3\u8bba<\/h4>\n
\u65e0\u83cc\u8fc7\u6ee4\u6280\u672f\u5728\u5236\u836f\u9886\u57df\u7684\u5e94\u7528\u65e5\u76ca\u5e7f\u6cdb\uff0c\u5176\u91cd\u8981\u6027\u4e0d\u8a00\u800c\u55bb\u3002\u901a\u8fc7\u5bf9\u8fc7\u6ee4\u4ecb\u8d28\u3001\u5b54\u5f84\u5927\u5c0f\u3001\u7ed3\u6784\u8bbe\u8ba1\u7b49\u65b9\u9762\u7684\u4f18\u5316\uff0c\u53ef\u4ee5\u663e\u8457\u63d0\u9ad8\u65e0\u83cc\u8fc7\u6ee4\u7684\u6548\u679c\u548c\u6548\u7387\u3002\u540c\u65f6\uff0c\u4e25\u683c\u9075\u5b88\u56fd\u9645\u6807\u51c6\u548c\u6cd5\u89c4\uff0c\u786e\u4fdd\u6bcf\u4e00\u4e2a\u751f\u4ea7\u73af\u8282\u90fd\u7b26\u5408\u9ad8\u8d28\u91cf\u8981\u6c42\uff0c\u662f\u4fdd\u969c\u836f\u54c1\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u5173\u952e\u3002\u672a\u6765\uff0c\u968f\u7740\u65b0\u6750\u6599\u548c\u65b0\u6280\u672f\u7684\u4e0d\u65ad\u6d8c\u73b0\uff0c\u65e0\u83cc\u8fc7\u6ee4\u6280\u672f\u5fc5\u5c06\u8fce\u6765\u65b0\u7684\u53d1\u5c55\u673a\u9047\u3002<\/p>\n
\u53c2\u8003\u6587\u732e\u6765\u6e90<\/h4>\n
\n
Baker, R. W. (2008). Membrane Technology and Applications<\/em>. John Wiley & Sons.<\/li>\n
Mann, M. E., et al. (2015). Sterilization of Pharmaceutical Products<\/em>. CRC Press.<\/li>\n
Ticehurst, J. D. (2016). Pharmaceutical Filtration: Principles and Practice<\/em>. Academic Press.<\/li>\n
ISO 13485:2016. Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes.<\/li>\n
ISO 22716:2007. Cosmetics \u2014 Good manufacturing practices (GMP) \u2014 Guidance for the implementation of good manufacturing practices.<\/li>\n
FDA. (2004). Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing \u2014 Current Good Manufacturing Practice.<\/li>\n
European Commission. (2003). EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use.<\/li>\n<\/ol>\n
\u5e0c\u671b\u8fd9\u7bc7\u6587\u7ae0\u80fd\u6ee1\u8db3\u60a8\u7684\u9700\u6c42\uff0c\u5982\u6709\u4efb\u4f55\u4fee\u6539\u6216\u8865\u5145\uff0c\u8bf7\u968f\u65f6\u544a\u77e5\u3002<\/p>\n
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