药品生产企业清洁验证常见问题探讨

Discussion on the Common Problems and Defects of Cleaning Verification in Pharmaceutical Manufacturing Enterprises

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.