江西省药品现代化物流作业设备验证分析  

Validation analysis of modernized logistics operation equipment for pharmaceuticals in Jiangxi Province

作　　者：徐小彬 孙寅田 林鹏 朱智青 XU Xiaobin;SUN Yintian;LIN Peng;ZHU Zhiqing(Jiangxi Provincial Drug Inspector Center,Nanchang 330029,China)

机构地区：[1]江西省药品检查员中心,南昌330029

出　　处：《上海医药》2025年第3期70-73,共4页Shanghai Medical & Pharmaceutical Journal

基　　金：江西省药品监督管理局科研项目(2023GL26)。

摘　　要：本文对江西省药品现代化物流作业设备验证进行分析,研究了验证对象、定义与价值,探讨了风险管理方法,分析了传输线、AGV小车和计算机信息管理系统的关键验证项目,并提出了验证数据的采集与利用分析方法。同时,指出了江西省药品批发企业在验证中存在的缺陷,探讨了验证的局限性和新兴技术的应用潜力,旨在为药品现代化物流作业设备验证工作的有效开展及药品监管提供参考。The validation of modernized logistics operation equipment for pharmaceuticals in Jiangxi Province was analyzed.The validation targets,definitions,and values were studied,the methods for risk management were explored,and the key validation items for conveyors,AGV carts,and computer information management systems were analyzed.Additionally,the methods for data collection and utilization analysis in validation were proposed.Meanwhile,the deficiencies in validation in pharmaceutical wholesale enterprises of Jiangxi Province were also pointed out,and the limitations of validation and the potential application of emerging technologies were discussed,thereby providing references for the effective implementation of validation work and pharmaceutical supervision.

关 键 词：药品现代化物流企业 现代化物流作业设备 验证 

分 类 号：R951[医药卫生—药学]