我国无菌药品生产与欧盟GMP要求的主要不同点

来源 :医药工程设计 | 被引量 : 0次 | 上传用户:xueluowushengkk
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我国的药品在保证质量的同时要走出国门,必须符合国际标准并取得FDA或欧盟GMP等国际权威GMP的认证.因此,要了解并掌握发达国家和世界先进卫生组织对GMP的要求和国际最新动向.主要将中国GMP和欧盟GMP对保证无菌药品生产质量中的不同要求进行比较,希望能为无菌药品按欧盟GMP标准进行医药工程设计提供一些参考.
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