WHO药品检验实验室预认证推动我国药品检验检测机构的国际化

WHO Prequalification Program on Drug Quality Control Laboratories Promotes the Internationalization of Drug Quality Control Laboratories in China

目的:帮助我国药品检验机构了解并申请世界卫生组织(WHO)药品检验实验室认证项目。方法:参考WHO发布的信息和文献报道,结合实验室现场辅导和检查的体会,从促进检验检测国际化的角度进行分析。结果:介绍了WHO药品检验实验室预认证的目的、适用的检验项目、评估标准、运行程序;回顾了该项目在全球和中国的执行情况;结合实例,深入理解对预认证检查的认识。结论:通过执行符合国际标准的实验室质量管理体系,该项目使我国药品检验机构具备为国际机构和组织提供检测服务的能力和水平。

Objective： The paper aims to facilitate the understanding and even the application of drug quality control laboratories in China on WHO Prequalification Program on drug quality control laboratories.Methods：From the viewpoint of internationalization of drug quality control laboratories,the paper is organized by referring to public information on WHO homepage and relevant academic materials,and by considering the observations during sites inspection and technical support on sites.Results：This paper provides basic information of WHO Prequalification Program on drug quality control laboratories in terms of rational for setting up this program,eligible testing items,assessment standards,procedure.It reviews the operation of this program abroad and in China.With examples,this paper discusses common issues arisen from site inspections.Conclusion：With quality management system in line with international standards,the WHO Prequalification Program makes drug quality laboratories in China be qualified to provide service for international community and organizations.