国外药品检查机构质量体系构建指南介绍及对我国的启示

A Guide to the Construction of Quality System in International Pharmaceutical Inspectorates and Its Enlightenment to China

目的:分析目前国际通行的药品检查机构质量管理体系要求,结合我国实际,为我国各级药品检查机构构建和完善质量管理体系提供建议。方法:通过文献研究法分析目前国际上对药品检查机构质量管理体系的要求,探究对我国构建药品检查机构质量管理体系的启示。结果与结论:国际社会在质量管理体系的基础上,形成了更符合药品检查机构实际的构建指南。本文结合我国国家、省、市多级药品检查机构的特点,从建好质量管理体系、突出药品检查特点、加强对外协作三方面为我国各级药品检查机构构建和完善协调统一的质量管理体系提供建议,以促进检查结果的互信互认。

Objective: To provide suggestions for the construction and improvement of the quality management system(QMS) at all levels in China by studying the current international requirements of the QMS of pharmaceutical inspectorates while combining the actual situation in China. Methods: The current international guidelines for the QMS of pharmaceutical inspectorates were analyzed by literature research so as to explore the enlightenment for the construction of the QMS of pharmaceutical inspectorates in China. Results and Conclusion: The international community has formed practical construction guidelines for the pharmaceutical inspectorates on the basis of the QMS. This paper puts forward suggestions for establishing and improving a coordinated and unified QMS for pharmaceutical inspectorates at all levels such as national, provincial and municipal institutions in China while combining the characteristics of multi-level pharmaceutical inspection institutions from three aspects, including establishing QMS, highlighting the characteristics of pharmaceutical inspection and strengthening external cooperation, so as to promote mutual recognition and inspection reliance.