江西省药品经营企业GSP监督检查缺陷项目分析  

Analysis of Defect Items in GSP Supervision and Inspection of Pharmaceutical Trading Enterprises in Jiangxi Province

作　　者：蔡锦尚 程一鑫 丁若雯 熊菲 CAI Jin-shang;CHENG Yi-xin;DING Ruo-wen;XIONG Fei(Jiangxi Provincial Drug Inspector Center;Jiangxi Province Adverse Drug Reaction Monitoring Center;Jiangxi Provincial Drug Administration)

机构地区：[1]江西省药品检查员中心 [2]江西省药品不良反应监测中心 [3]江西省药品监督管理局

出　　处：《中国食品药品监管》2023年第11期84-91,共8页China Food & Drug Administration Magazine

基　　金：江西省药品监督管理局科研项目(2021KY04)。

摘　　要：目的:本研究旨在为江西省药品经营企业(含药品批发企业和药品零售连锁企业总部)提供有效的药品经营质量管理规范(GSP)监督检查指导,以提高其药品经营质量管理水平。方法:通过对2021~2022年期间江西省药品经营企业GSP监督检查中发现的缺陷项目进行综合分析,确定常见的缺陷项目类型,提炼出影响其质量管理的主要原因,并提出相应的改进措施。结果与结论:为确保药品经营质量管理的有效性,药品经营企业应当加强对质量管理的认知,提高培训的针对性,加强对仓储水平的管理,为企业持续符合GSP标准奠定坚实的基础。Objective:This study aims to provide effective guidance on the supervision and inspection of Good Manufacturing Practice(GSP)for pharmaceutical trading enterprises in Jiangxi Province,including headquarters of pharmaceutical wholesale enterprises and pharmaceutical retail chain enterprises,to improve their pharmaceutical trading quality management.Methods:A comprehensive analysis of defect items found during the GSP supervision and inspection of pharmaceutical trading enterprises in Jiangxi Province from 2021 to 2022 was conducted.Common types of defect items are identified,and the main reasons affecting their quality management are extracted,along with corresponding improvement measures.Results and Conclusion:To ensure the effectiveness of pharmaceutical trading quality management,enterprises should strengthen their awareness of quality management,improve training relevance,and strengthen warehouse management.These steps will lay a solid foundation for enterprises to continuously comply with GSP standards.

关 键 词：药品经营企业 药品经营质量管理规范 监督检查 缺陷项目 

分 类 号：R95[医药卫生—药学]