安徽省药品批发企业许可检查缺陷项目分析

Analysis of Defects in License Inspection of Pharmaceutical Wholesale Enterprises in Anhui Province

目的通过对安徽省2019年药品批发企业许可检查中的缺陷问题汇总分析,为加强监管和提高企业质量管理水平提供参考。方法对2019年药品批发企业检查情况进行汇总,分析检查类型,并对275家许可检查结果进行统计,汇总出高频缺陷,分析存在的主要问题和原因,并提出相关建议。结果安徽省2019年许可换证检查占总检查数的69.5%;共发现缺陷项3127项次,其中主要缺陷项目183项次,一般缺陷项目2944项次,平均每家11.4条缺陷项。企业存在的主要问题集中在质量体系、计算机系统、验证管理、温湿度控制等方面。结论监管部门应加快专职检查员队伍的建设,保障检查水平;企业应提高质量管理意识,规范药品经营行为,保障人民安全用药。

Objective To provide a reference for strengthening supervision and improving the level of enterprise quality management through a summary analysis of the defects in the licensing inspection of pharmaceutical wholesale enterprises in Anhui Province in 2019.Methods Summarize the inspections of pharmaceutical wholesale companies in 2019,analyzed the types of inspections,and count 275 sub-licensing inspection results,summarized high-frequency defects,analyzed the main problems and causes,and make relevant recommendations.Results Anhui Province's permit renewal inspections accounted for 69.5%of the total inspections in 2019;a total of 3127 defective items were found,including 183 major defective items and 2944 general defective items,with an average of 11.4 defective items per company.The main problems existing in the enterprise are concentrated in the aspects of quality system,computer system,verification management,temperature and humidity control,etc.Conclusion Regulatory departments should speed up the construction of a team of full-time inspectors to ensure the level of inspection;enterprises should improve their awareness of quality management,standardize drug business behavior,and ensure people's safe use of drugs.