除菌过滤器验证(一)：法规要求概述  

Validation of sterilizing grade filters(Ⅰ):an overall review of regulatory requirements

作　　者：黄晓龙[1,2] 董巍[1,2] 唐燕[1,2] 谢婷[1,2] 洪海燕[1,2] 蔡清波[1,2] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038 [2]颇尔中国生命科学部,上海201203

出　　处：《中国新药杂志》2011年第10期861-865,共5页Chinese Journal of New Drugs

摘　　要：文中介绍了液体除菌过滤和微生物污染水平控制过滤的区别,并结合历史发展阐释了现行法规对液体除菌过滤的定义。在此基础上,重点结合国外法规要求,对除菌过滤器的相关验证要求和项目进行了综述。This article introduced the difference between sterilizing filtration and the filtration for controlling microbial contamination,also stated the current regulatory identification of sterilizing filtration in view of the historical developments.This review emphasized on the requirements of qualification/validation and related items for sterilizing grade filter on the basis of regulations abroad.

关 键 词：除菌过滤 除菌过滤器 法规要求 确认 验证 

分 类 号：R95[医药卫生—药学]