药品生产设备清洁验证要点及缺陷分析

Key points and defects analysis of cleaning validation of drug manufacture equipment

通过对国内外药品生产设备清洁验证的相关法规指南全面梳理,从质量管理体系及验证工作生命周期管理的角度对清洁验证进行了分析;明确了药品生产设备清洁验证要点并构建了要点结构图;对国内外药品检查中发现的药品生产设备清洁验证存在的缺陷进行了统计分析;对清洁验证常见问题及分布情况进行识别,为我国药品生产企业进一步做好药品生产设备清洁验证提供思路与参考,同时也为药品检查工作中对清洁验证针对性检查提供借鉴。

The GMP requirement and guidelines about cleaning validation of drug manufacture equipment study are analyzed,and the key points of the cleaning validation structure of drug manufacture equipment from the views of the quality management system and the life cycle of cleaning validation are established,and a statistical analysis on the cleaning validation observations in domestic and overseas drug inspections in recent years are conducted.The distribution of major observations and common problems existing in cleaning validation are identified.The study provides suggestions and reference to cleaning validation for industry,and gives some considerations and key points to on-site inspections about cleaning validation.