安徽省2022年中药饮片GMP符合性检查缺陷分析及建议  

Defective Items Analysis and Suggestions on the GMP Conformity Inspection of Chinese Herbal Pieces in Anhui Province

作　　者：李磊 罗京京 班永生 LI Lei;LUO Jingjing;BAN Yongsheng(Anhui Center For Drug Evaluation&Inspection,Hefei,Anhui,China 230051)

机构地区：[1]安徽省药品审评查验中心,安徽合肥230051

出　　处：《中国药业》2025年第9期11-15,共5页China Pharmaceuticals

摘　　要：目的提升中药饮片的质量。方法回顾性分析安徽省2022年39家次中药饮片生产企业《药品生产质量管理规范》(GMP)符合性检查发现的缺陷项目,总结存在的共性问题,并提出针对性建议。结果共发现检查缺陷项439项,其中严重缺陷6项、主要缺陷26项、一般缺陷407项,主要集中在质量控制与质量保证(23.01%)、文件管理(18.00%)、确认与验证(11.39%)、中药饮片附录(11.16%)、机构与人员(9.79%)、设备(6.61%)、厂房与设施(5.47%)、生产管理(5.01%)、物料与产品(3.87%)等方面。结论中药饮片生产企业应增强质量意识、强化人员培训、提升检验能力、规范文件管理、完善设备确认工作等,以健全药品生产质量管理体系;监管部门应完善监管体系建设,形成监管合力,并通过构建中药饮片生产信息化追溯体系实现智慧监管,保障中药饮片的质量。Objective To improve the quality of traditional Chinese herbal pieces.Methods A retrospective analysis was conducted on the defect items found in the conformity inspection of the Good Manufacturing Practice(GMP)of 39 Chinese herbal pieces manufacturers in Anhui Province in 2022 to summarize the common problems,and targeted suggestions were put forward.Results A total of 439 inspection defects were found,including six serious defects,26 major defects,and 407 general defects,mainly concentrated in quality control and quality assurance(23.01%),document management(18.00%),confirmation and verification(11.39%),Appendix of Chinese herbal pieces(11.16%),organizations and personnel(9.79%),equipment(6.61%),plant and facilities(5.47%),production management(5.01%),materials and products(3.87%),and other aspects.Conclusion Chinese herbal pieces manufacturers should enhance quality awareness,strengthen personnel training,improve inspection capabilities,standardize document management,and improve equipment verification to improve the quality management system of drug production.Drug regulatory authorities should improve the construction of the supervision system to form the supervision force,and realize intelligent supervision by constructing the information-based traceability system of Chinese herbal pieces production,in order to ensure the quality of Chinese herbal pieces.

关 键 词：中药饮片生产企业 《药品生产质量管理规范》符合性检查 缺陷分布 安徽省 

分 类 号：R932[医药卫生—生药学] R288[医药卫生—药学]