通過對國內(nèi)外藥品生產(chǎn)設(shè)備清潔驗證的相關(guān)法規(guī)指南全面梳理，從質(zhì)量管理體系及驗證工作生命周期管理的角度對清潔驗證進行了分析；明確了藥品生產(chǎn)設(shè)備清潔驗證要點并構(gòu)建了要點結(jié)構(gòu)圖；對國內(nèi)外藥品檢查中發(fā)現(xiàn)的藥品生產(chǎn)設(shè)備清潔驗證存在的缺陷進行了統(tǒng)計分析；對清潔驗證常見問題及分布情況進行識別，為我國藥品生產(chǎn)企業(yè)進一步做好藥品生產(chǎn)設(shè)備清潔驗證提供思路與參考，同時也為藥品檢查工作中對清潔驗證針對性檢查提供借鑒。

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.

R925