美国食品和药物管理局2019—2023财政年度GMP检查缺陷数据分析  

Analysis of the FDA Drug GMP Inspection Observations from Fiscal Year 2019 to 2023

作　　者：陆德 许文艳 葛渊源 张景辰 LU De;XU Wenyan;GE Yuanyuan;ZHANG Jingchen(Yangtze River Delta Center for Drug Evaluation and Inspection of NMPA,Shanghai,China 201203;Shanghai Center for Evaluation and Inspection,Shanghai,China 201203)

机构地区：[1]国家药品监督管理局药品审评检查长三角分中心,上海201203 [2]上海药品审评核查中心,上海201203

出　　处：《中国药业》2024年第23期16-21,共6页China Pharmaceuticals

摘　　要：目的提升企业药品生产质量管理水平。方法统计美国食品和药物管理局(FDA)2019年至2023年财政年度(简称财年)发布的药品项下的483表格缺陷,分别按缺陷编号、引用条款号、药品生产质量管理规范(GMP)章节进行分析,并总结相应启示。结果综合缺陷编号及引用条款号,FDA发现在质量管理、偏差管理、书面记录及工艺控制规程、实验室及微生物控制等方面的缺陷较多。结论企业应建立药品全生命周期的质量管理制度及处理偏差的操作规程,药品监管机构可利用信息化技术加强对药品的监管。Objective To improve the quality management level of pharmaceutical production in enterprises.Methods Statistical analysis was conducted on the form 483 inspection observations under the drug category released by the US Food and Drug Administration(FDA)from fiscal year 2019 to 2023.The data were analyzed by the cite ids,citation clause number and Good Manufacturing Practice(GMP)chapters respectively,and corresponding insights were summarized.Results Combined cite ids and citation clause numbers,FDA found more deficiencies in quality management,deviation management,written records and process control procedures,laboratory and microbial control.Conclusion Enterprises should establish a quality management system for the entire life cycle of drugs and operating procedures for handling deviations.Drug regulatory agencies should strengthen drug supervision through information technology.

关 键 词：检查缺陷 483表格 质量管理 偏差管理 美国食品和药物管理局 

分 类 号：R95[医药卫生—药学]