摘要
清洁验证作为保障药品生产质量的关键内容,有必要作为专题进行分析研究。本文通过笔者在2017~2019年参加国家、湖北省组织对药品生产企业现场检查过程中发现的有关清洁验证常见问题缺陷做了梳理和分类;为药品生产企业清洁验证工作的有效开展提供了参考和思路,同时也为药品生产监管及检查工作中对清洁验证方面的针对性检查提供借鉴。
As the key content to ensure the quality of drug production, it is necessary to analyze and study it as a special topic. In this paper, the author organized by the state and Hubei Province in 2017~2019 to sort out and classify the common problems and defects of cleaning verification found in the process of on-site inspection of drug production enterprises;it provides reference and ideas for the effective implementation of cleaning verification work of drug production enterprises, and also provides targeted inspection on cleaning verification in drug production supervision and inspection Reference.
作者
何本霞
成立
张清
He Benxia;Cheng Li;zhang Qing(Center for Evaluation and Inspection of Hubei Drug Administration,Wuhan 430071;Huangshi food and drug inspection and Testing Center,Huangshi,435000,China)
出处
《广东化工》
CAS
2020年第24期219-220,共2页
Guangdong Chemical Industry
关键词
清洁验证
药品生产企业
缺陷
cleaning validation
pharmaceutical manufacturers
defects