药品生产质量管理中管理评审探讨与常见问题分析  

The Discussion of Management Review and Analysis of Common Deficiencies in Good Manufacturing Practice for Medicine

作　　者：颜若曦 YAN Ruoxi(Center for Food and Drug Inspection of NMPA,Beijing 100076,China)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,北京100076

出　　处：《中国药物评价》2025年第1期78-80,共3页Chinese Journal of Drug Evaluation

摘　　要：本研究在对国内外药品生产质量管理规范中有关管理评审相关规定进行总结的基础上,对近几年国外药品生产检查发现的管理评审相关缺陷进行了统计分析,从管理评审内容、管理评审程序文件与执行、问题识别分析与结论、记录与报告和评审周期等6个方面提炼出药品生产质量管理中的管理评审的常见缺陷,为我国药品生产企业进一步做好管理评审,持续改进质量管理体系提供思路与参考。Based on the summary of relevant requirements on management review in domestic and foreign Good Manufacturing Practice standards,the study conducts a statistical analysis of the management review-related deficiencies found in foreign medicine manufacture inspections in recent years.Common deficiencies in management review in medicine manufacture quality management were extracted from six aspects:management review contents,management review procedure and implementation,problems identification analysis and conclusion,records and reports,and review frequency.It provides references for medicine manufacturers to further improve their management review and continuously improve their quality management system.

关 键 词：药品生产质量管理规范 管理评审 质量管理 药品检查 

分 类 号：R95[医药卫生—药学]