药品生产的偏差处理  

Deviation handling for the pharmaceutical manufacturing process

作　　者：于庆华[1] 张璇[1] 

机构地区：[1]上海现代制药股份有限公司,上海200137

出　　处：《上海医药》2016年第11期74-77,共4页Shanghai Medical & Pharmaceutical Journal

摘　　要：偏差处理是GMP管理的关键要素,也是GMP执行过程中的难点之一。科学地进行偏差调查并合理制定相应的纠正和预防措施是药品生产、质量管理过程中能够严格执行GMP的保障之一。本文通过对药品生产过程中的偏差处理流程和偏差处理的要点及难点进行综述性的讨论,对药品生产、检验过程中的偏差处理方法提供建议,对GMP执行过程中的重要因素——偏差处理进行了详尽的解读和分析。Deviation handling is a key factor of GMP management and one of the difficult points in the process of GMP implementation. Scientific deviation investigation and reasonable CAPAs can ensure that the GMP would be strictly carried out. This article discusses deviation procedure and key and difficult points of deviation handling in drug manufacturing process, provides some proposals for the method handling deviation in drug manufacturing and testing process, and interprets and analyzes deviation, which is a key factor in the process of GMP implementation.

关 键 词：偏差处理 GMP 纠正和预防措施 风险评估 

分 类 号：R95[医药卫生—药学]