WHO药品预认证中仪器设备管理经验总结  

Equipment management experience in the WHO prequalification

作　　者：王冠杰[1] 田利[1] 项新华[1] 陈为[1] 曹守春[1] 邹健[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国医药导报》2013年第2期156-157,共2页China Medical Herald

基　　金：国家高技术研究发展计划(863计划)课题(课题编号:2012AA02A402)

摘　　要：WHO的药品预认证项目是一个由WHO代表联合国来管理和运作的项目,体现一个国家的药品质量控制达到了国际标准,而仪器设备管理是WHO预认证的重点考察对象之一。本文将GPCL与CNAS-CL01:2006对仪器设备管理要求进行对比,介绍了了两者之间的差异,从仪器设备的规章制度、运行管理、性能确认三方面总结WHO药品预认证经验,为申请WHO预认证提供仪器设备管理经验,也为药检机构顺利通过WHO预认证提供保障。The WHO prequalification project is managed and operated by WHO on behalf of the United Nations,which reflects drugs reaching the international standards.Equipment management is the most important objects in WHO prequalification.The differences between the GPCL and CNAS-CL01： 2006 are described in equipment requirements,and experience is summed up in the rules and regulations of the equipment,operation and management,performance qualification in the WHO prequalification,which provides equipment management experience to apply for WHO prequalification and pass the drug test institutions WHO prequalification.

关 键 词：WHO药品预认证 仪器设备 性能 

分 类 号：R95[医药卫生—药学]