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_黄宝斌.pdfVIP

1354 Chinese Journal of Medicinal Guide 2014 Volume 16 No. 10(Serial No.132) 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# 黄宝斌,许明哲,杨青云,田学波,白东亭* (中国食品药品检定研究院综合业务处,北京 100050) 【摘要】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。 【关键词】 WHO；药品检验实验室；认证；国际化 【中图分类号】 R927.1 【文献标识码】 B 【文章编号】1009-0959(2014)10-1354-03 WHO Prequalification Program on Drug Quality Control Laboratories Promotes the Internationalization of Drug Quality Control Laboratories in China Huang Bao-bin,Xu Ming-zhe,Yang Qing-yun,et al. (National Institutes for Food and Drug Control,Beijing 100050, China) ABSTRACT 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 di