我国化学药生产企业境外检查观察情况分析  

International Drug Inspection and Observation of Chinese Chemical Pharmaceutical Production Enterprises

作　　者：徐长波 翟铁伟 XU Changbo;ZHAI Tiewei(Center for Food and Drug Inspection of NMPA,Beijing,China 100044)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,北京100044

出　　处：《中国药业》2024年第3期38-42,共5页China Pharmaceuticals

摘　　要：目的促进我国化学药生产企业质量管理能力提升。方法通过分析2015年至2022年我国化学药生产企业境外检查观察情况及检查发现缺陷分布,总结境外检查重点和高频缺陷的类别。结果2015年至2022年,24个境外药品监管机构对我国化学药生产企业完成443家次境外检查,发现缺陷4854项。2015年至2019年,境外药品监管机构检查家次数逐年上升,分别为74,81,84,82,102家次;2020年至2022年,受新型冠状病毒感染疫情影响,境外检查次数明显减少,分别为6,6,8家次。2015年至2019年,世界卫生组织(WHO)、欧洲药品质量理事会(EDQM)、美国食品和药物管理局(FDA)检查发现的次均缺陷数分别约为20,20,5项;严重缺陷主要由数据可靠性问题引起,但发生次数占比逐年降低。2019年,国家药品监督管理局食品药品审核查验中心共检查观察境外药品监管机构102家次,发现缺陷793项,排序前三的高频缺陷有质量控制与质量保证、文件管理、确认与验证,分别占32.53%,14.88%,13.75%。结论不同境外药品监管机构的检查重点及高频缺陷类别基本类似。我国化学药生产企业在质量控制与质量保证、确认与验证、文件管理等方面与国际水平仍存在差距。我国药品生产企业应根据实际情况,持续提升生产质量管理水平;我国药品监管机构应基于上述风险深入开展药品检查,促进企业质量管理能力全面提升。Objective To promote the improvement of quality management capabilities in Chinese chemical pharmaceutical production enterprises.Methods The international drug inspection and observation of Chinese chemical pharmaceutical production enterprises from 2015 to 2022,and the distribution of defects found during inspection were analyzed.The key points of international drug inspection and the categories of high-frequency defects were summarized.Results From 2015 to 2022,24 overseas pharmaceutical regulatory agencies completed 443 international inspection of Chinese chemical pharmaceutical production enterprises,and found 4854 defects.From 2015 to 2019,the number of inspections from overseas pharmaceutical regulatory agencies increased year by year,with 74,81,84,82,and 102 times,respectively.From 2020 to 2022,the number of overseas inspections significantly reduced because of the COVID-19 epidemic,with 6,6 and 8 times,respectively.From 2015 to 2019,the World Health Organization(WHO),European Directorate for the Quality of Medicines(EDQM),and Food and Drug Administration(FDA)found 20,20,and 5 defects per inspection,respectively.Serious defects were mainly caused by data reliability issues,but the proportion of occurrences decreased year by year.In 2019,the Center for Food and Drug Inspection of NMPA inspected 102 overseas pharmaceutical regulatory agencies and found 793 defects.The Top three high-frequency defects were quality control and assurance,document management,confirmation and verification,accounting for 32.53%,14.88%,and 13.75%,respectively.Conclusion The inspection focus and high-frequency defect categories of different overseas pharmaceutical regulatory agencies are basically similar.There is still a gap between Chinese chemical pharmaceutical production enterprises and the international level in terms of quality control and assurance,confirmation and verification,and document management.Chinese pharmaceutical production enterprises should continuously improve their production quality management level based on

关 键 词：化学药品 境外检查观察 药品生产质量管理规范 

分 类 号：R95[医药卫生—药学]