国外药品GMP检查员管理体系对我国药品检查员队伍专职化的启示

On Foreign Drug GMP Inspector Management System and Its Enlightenment on Specialization of Drug Inspector Team in China

目的:分析我国目前药品GMP检查员制度的现状,对比分析美国、欧盟、英国的药品GMP检查员制度,探讨如何建立我国GMP药品专职检查员制度、建设专职检查员队伍。方法:从药品GMP检查员的编制、分级制度、工作内容及培训制度四个方面对比,分析国内外药品GMP检查员制度。结果与结论:与其他国家或组织相比,我国GMP检查员的专职化在各方面有明显差距。因此,解决专职检查员的编制、合理设置分级制度、细化专职检查员工作内容、科学系统化专职检查员的培训内容是建设我国专职药品GMP检查员队伍待解决的问题。

Objective:To analyze the current status of drug GMP inspector system in China,to compare and analyze the GMP inspector systems in the United States,the European Union and the United Kingdom,and to discuss how to establish a full-time GMP inspector system and build a full-time inspector team in China.Methods:The drug GMP inspector systems at home and abroad were compared and analyzed from four aspects:positions,rating system,work contents and training system of drug GMP inspectors.Results and Conclusion:In comparison with other countries or organizations,the specialization of GMP inspectors in China has a clear gap in all aspects.Therefore,The issues to be solved in the establishment of a full-time drug GMP inspector team in China are the establishment of full-time inspectors,the reasonable setting of grading system,the refinement of the work contents of full-time inspectors,and the scientific systematization of the training contents of full-time inspectors.