摘要
根据生命周期理论,清洁验证可分为清洁工艺开发、清洁确认、持续清洁确认3个阶段。应当建立清洁验证的生命周期,并在药品生命周期内持续考察清洁方法的有效性:首先进行清洁工艺开发,然后在生产过程中进行清洁确认,最后通过日常监测,进行持续清洁确认。
According to the life cycle theory, the life cycle of the cleaning validation is divided into three stages: cleaning process design, cleaning qualification, and continued cleaning verification. The life cycle of the cleaning validation should be established and the effectiveness of the cleaning process should be continuously investigated throughout the life cycle of the drug. After the cleaning design is confirmed, the cleaning qualification should be completed in the production, and the daily cleaning monitoring measures should be established to carry out continued cleaning verification.
作者
翟铁伟
ZHAI Tiewei(Center for Food and Drug Inspection of NMPA,Beijing 100044)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2019年第11期1341-1347,共7页
Chinese Journal of Pharmaceuticals
关键词
生命周期
清洁验证
清洁工艺开发
清洁确认
持续清洁确认
life cycle
cleaning validation
cleaning process design
cleaning qualification
continued cleaning verification
