中药饮片GMP检查典型缺陷分析及对中药饮片质量监管的启示  

Analysis of Typical Defects in GMP Inspection of Chinese Herbal Pieces and Its Enlightenment on Quality Supervision of Chinese Herbal Pieces

作　　者：袁建龙 张江清 吴春敏 黄榕珍 Yuan Jianlong;Zhang Jiangqing;Wu Chunmin;Huang Rongzhen(Fujian Center for Drug Evaluation and Monitoring,Fuzhou 350003,China;Fujian Center for Drug Inspection,Fuzhou 350003,China)

机构地区：[1]福建省药品审评与监测评价中心,福州350003 [2]福建省药品审核查验中心,福州350003

出　　处：《中国药事》2022年第11期1222-1228,共7页Chinese Pharmaceutical Affairs

基　　金：福建省药品监督管理局2020年度药品安全监管科研项目“基于风险管理的药品GMP检查策略”(编号2020001)。

摘　　要：目的:为中药饮片生产企业实施GMP提出改进措施,为加强中药饮片生产监管提供对策建议。方法:采用回顾性研究分析方法,以2018年1月至2021年6月福建省开展的33家次中药饮片GMP检查结果为研究对象,对检查发现的缺陷项目进行统计分析。结果:共发现检查缺陷项408项,其中主要缺陷29项,一般缺陷379项,主要集中在机构与人员、质量控制与质量保证、厂房设施与设备、确认与验证、文件管理等方面。结论:企业应从强化人员培训、提升检验能力、扎实开展自检等方面着手完善质量管理体系。建议药品监督管理部门加强共性问题研究,运用智慧监管手段提升中药饮片监督检查效能,保障公众用药安全有效。Objective:To propose improvement measures for the implementation of GMP for Chinese herbal pieces production enterprises,and provide countermeasures and suggestions for strengthening the supervision and management of Chinese herbal pieces production.Methods:Retrospective research and analysis methods were adopted,and the GMP inspection results of 33 sub-Chinese herbal pieces carried out in Fujian Province from January 2018 to June 2021 were taken as the research objects,and statistical analysis on the defects found in the inspection was conducted.Results:A total of 408 inspection defects were found,including 29 major defects and 379 general defects,which were mainly in the aspects of organization and personnel,quality control and quality assurance,plant facilities and equipment,qualification and validation,documentation management,etc.Conclusion:Chinese herbal pieces production enterprises should start to improve the quality management system in terms of strengthening personnel training,improving inspection capabilities,and solidly carrying out self-inspection.It is recommended that the drug regulatory authorities should strengthen research on common issues,use smart supervision methods to improve the effectiveness of supervised inspection of Chinese herbal pieces,and ensure the safety and effectiveness of public medication.

关 键 词：中药饮片 GMP检查 缺陷 监管 质量 

分 类 号：R95[医药卫生—药学]