我国无菌药品生产与欧盟GMP要求的主要不同点

Main Differences between GMP Requirements of EU and Non-bacteria Drug Production in China

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。

In order to export to foreign countries, the drugs made in China must be in accordance with international standards and be approved by FDA or authorized GMP organization, such as EU GMP. Thus, it is necessary to know the requirements of advanced world health organizations to GMP and the development in the field. In this article, the different requirements of GMP in China and EU to the quality of non-bacteria drug in production were compared. It is hoped that what presented herein can be referenced in pharmaceutical engineering design for non-bacteria drag production in accordance with EU GMP.