江西省2022年度药品GMP检查缺陷分析与研究  

Jiangxi Province 2022 Annual Drug GMP Inspection Deficiency Analysis and Research

作　　者：漆亮 洪玲洁 宋宇 QI Liang;HONG Lingjie;SONG Yu(Jiangxi Province Drug Certification and Review Center,Nanchang Jiangxi 330006,China)

机构地区：[1]江西省药品认证审评中心,江西南昌330006

出　　处：《药品评价》2023年第11期1301-1305,共5页Drug Evaluation

基　　金：江西省药品监督管理局科研项目(2021KY16)。

摘　　要：收集2022年度江西省药品生产质量管理规范(good manufacturing practice,GMP)检查的相关数据,采用文献综述和实证研究相结合的方法,统计分析药品生产过程中存在的显著问题,提出改进建议包括加强培训和指导、提升生产质量管理体系、加强原料质量控制等。This paper analyzed the work related to drug GMP inspection in Jiangxi Province in 2022,aiming to put forward a series of practical improvement measures to improve enterprise risk management awareness through its completion,existing problems and data analysis.This study adopted the method of literature review and empirical study,collected the relevant data of drug GMP inspection in Jiangxi Province,and analyzed the defects by statistical analysis.In view of the obvious problems existing in the drug production process,suggestions for improvement were put forward,including strengthening training and guidance,improving production quality management system,and strengthening raw material quality control.These recommendations are important for improving the quality of pharmaceutical production and ensuring public health and safety.

关 键 词：生产质量管理规范(GMP) 药品生产质量管理规范(GMP)检查 缺陷分析 改进措施 

分 类 号：R95[医药卫生—药学]