2021年江西省疫苗配送企业检查情况分析  

Analysis on the Inspection of Vaccine Distribution Enterprises 2021 in Jiangxi Province

作　　者：吴凡 喻文进 胡媛 杨洁 梅俊俊 涂司武 WU Fan;YU Wenjin;HU Yuan;YANG Jie;MEI Junjun;TU Siwu(Jiangxi Drug Inspection Center,Nanchang Jiangxi 330001,China)

机构地区：[1]江西省药品检查员中心,江西南昌330001

出　　处：《药品评价》2022年第12期708-710,共3页Drug Evaluation

基　　金：江西省药品监督管理局科研项目(2021KY21)。

摘　　要：目的:促进疫苗配送企业严格执行《疫苗管理法》《药品经营质量管理规范》(2016版)和《疫苗储存和运输管理规范》(2017版)等法律法规,保障产品质量安全。方法:从检查内容、结果和缺陷项数量、类型、频次等方面,对6轮疫苗配送企业共36次检查缺陷项进行统计,并对企业存在的主要问题进行分析。结果:缺陷项主要集中在人员与培训(占比8.8%)、质量管理体系文件(占比12.8%)、设施与设备(占比29.6%)、收货与验收(占比8.0%)、储存与养护(占比18.4%)等五个方面。结论:质量管理水平不高、质量体系文件执行力不够及忽视人员教育培训工作是当前疫苗配送企业主要风险点。Objective:Promote vaccine distribution enterprises to strictly implement laws and regulations such as the Vaccine Management Law,the Code for the Quality Management of Drug Operation (2016 Edition) and the Code for the Management of Vaccine Storage and Transportation (2017 Edition) to ensure product quality and safety.Methods:From the aspects of inspection contents,results,quantity,type and frequency of defective items,the inspection defective items of 36 vaccine distribution enterprises were counted,and the main problems existing in the enterprises were analyzed.Results:The defects were mainly concentrated in five aspects:personnel and training (8.8%),quality management system documents (12.8%),facilities and equipment (29.6%),receiving and acceptance (8.0%),storage and maintenance (18.4%).Conclusion:Low quality management level,insufficient execution of quality system documents and neglect of personnel education and training are the main risk points of vaccine distribution enterprises.

关 键 词：疫苗配送企业 致冷 检查 缺陷项 风险点 

分 类 号：R95[医药卫生—药学] F426.72[经济管理—产业经济]