药品经营企业计算机管理信息系统GSP检查体系的建立  

Establishment of GSP Inspection System for Computer Management Information System of Drug Trading Enterprises

作　　者：肖旭坤 赵静 XIAO Xukun;ZHAO Jing(Department of Scientific Research,Zhejiang Pharmaceutical University,Ningbo,Zhejiang,China 315500;School of Business,Zhejiang Pharmaceutical University,Ningbo,Zhejiang,China 315500)

机构地区：[1]浙江药科职业大学科研处,浙江宁波315500 [2]浙江药科职业大学药商学院,浙江宁波315500

出　　处：《中国药业》2022年第16期31-35,共5页China Pharmaceuticals

基　　金：浙江省药品监督管理局2022年度科技计划项目[2022040];浙江省2019年度软科学研究计划项目[2019C35024]。

摘　　要：目的建立药品经营企业计算机管理信息系统《药品经营质量管理规范》(GSP)检查体系。方法借鉴相关文献,结合专家论证法,系统归纳GSP中相应的法规条款及2016年版国家《药品经营质量管理规范现场检查指导原则》中的对应检查项目,结合计算机系统的运行特点,运用模块化思路,建立药品经营企业计算机管理信息系统GSP检查体系。结果将检查内容分为计算机系统配置、业务流程控制和质量基础数据管理三大基础模块,每个模块再进一步分解,共得到17个二级模块,并针对每个二级模块提出对应的重点检查内容与检查方法。结论建立的检查体系,能提高药品检查效率,促进企业持续改进,从而保证药品质量管理活动有序、高效运行。Objective To establish a Good Supplying Practice(GSP)inspection system for the computer management information system of drug trading enterprises.Methods Based on the relevant literature,the expert argumentation,summary of the corresponding laws and regulations in the GSP and the corresponding inspection items in the 2016 edition of the national Guidelines for Drug GSP On-Site Inspection,combined with the operating characteristics of the computer system,and using the modular idea,the GSP inspection system for the computer management information system of pharmaceutical trading enterprises was established.Results The inspection items were divided into three basic modules:computer system configuration,business process control and quality basic data management.Each module was further decomposed,and 17 secondary modules were obtained.The corresponding key inspection items and inspection methods were proposed for each secondary module.Conclusion The established inspection system can improve the efficiency of drug inspection and promote the continuous improvement of enterprises,so as to ensure the orderly and efficient operation of drug quality management activities.

关 键 词：药品经营企业 药品经营质量管理规范 检查体系 计算机管理信息系统 药品质量管理 

分 类 号：R95[医药卫生—药学]