CAJ | 학술논문

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。
목적：방조아국약품검험궤구료해병신청세계위생조직(WHO)약품검험실험실인증항목。방법：삼고WHO발포적신식화문헌보도，결합실험실현장보도화검사적체회，종촉진검험검측국제화적각도진행분석。결과：개소료WHO약품검험실험실예인증적목적、괄용적검험항목、평고표준、운행정서；회고료해항목재전구화중국적집행정황；결합실례，심입리해대예인증검사적인식。결론：통과집행부합국제표준적실험실질량관리체계，해항목사아국약품검험궤구구비위국제궤구화조직제공검측복무적능력화수평。
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.