制药企业的文件管理

Document Management of Pharmaceutical Companies

目的讨论制药企业文件管理体系问题,为落实新版药品GMP中关于文件管理的相关要求提供参考意见。方法从文件体系的建立,文件质量的管理,文件的维护、变更等方面对实施GMP过程中文件管理方面的问题进行分析。结果与结论提高对文件管理的认识,细化文件管理过程,提升文件管理水平,可有效实现企业生产质量的管理。

Objective To provide some references for document management according to requirements in the new edition of GMP. Methods Problems exposed during the implementation process were discussed and recommendations were put forward. Results and Conclusion The concept of document management should be improved and the process of document management should be refined so as to improve the level of document management.