新版药品GMP实施过程中发现的问题及监管对策

The Problems Existing in the Implementation of the New Version of GMP and Regulatory Countermeasures

目的为监管部门推进新版药品GMP实施提供参考。方法对新版药品GMP实施以来发现的问题进行分析与总结,提出下一步的监管对策。结果与结论要从组织机构的建设、宣传培训、分类指导、完善制度、监督检查等方面入手,推进新版药品GMP实施进程。

Objective To provide a reference for the regulatory departments to promote the implementation of the new version of GMP.Methods Through Analyzed and summarized the existing problems since the implementation of the new version of GMP,proposed the next regulatory countermeasures.Results and Conclusion By the way of organizational construction,advocacy training,classified guidance,improving the system,supervision and inspection and other aspects,to promote the process of the implementation of the new version of GMP