药品零售连锁企业经营许可换证现场检查中常见问题分析与改进

Analysis and Improvement of Common Problems in on-Site Inspection of Business License Renewal of Drug Retail Chain Enterprises

目的为药品零售连锁企业经营许可现场检查提供参考,规范药品零售连锁企业的经营。方法统计重庆市2020年申请经营许可换证检查的29家药品零售连锁企业现场检查中存在的缺陷项目,汇总主要缺陷项目和一般缺陷项目,分析药品零售连锁企业换证现场检查中的常见问题,并提出改进措施。结果共发现缺陷项目219条,其中主要缺陷项目115条,一般缺陷项目104条。依据并严格执行相关要求,发现在质量管理体系及文件,收货、验收、储存与养护,计算机系统,机构和人员,出库、运输与配送,销售及售后,采购,设施与设备等方面均存在问题,缺陷项目分别为68条、34条、33条、30条、21条、17条、11条、5条。结论企业应按要求建立质量管理体系,应具有与其药品经营范围、经营规模相适应的经营场所、库房、设施设备等硬件条件;采用计算机系统保证经营全过程可追溯;药品零售连锁企业的现场检查应重点关注门店管理、货架管理、物流配送、药师在岗管理等方面。

Objective To provide a reference for the on-site inspection of business license of drug retail chain enterprises and standardize the operation of drug retail chain enterprises.Methods The defective items in the on-site inspection of 29 drug retail chain enterprises applying for the inspection of business license renewal in Chongqing in 2020 were counted,the main defective items and general defective items were summarized,the common problems in the on-site inspection of drug retail chain enterprises were analyzed,and the improvement measures were put forward.Results A total of 219 defective items were found,including 115 main defective items and 104 general defective items.According to and in strict accordance with the related requirements,it was found that there were problems in the quality management system and document,receiving,acceptance,storage and maintenance,computer system,institutions and personnel,ex-warehouse,transportation and distribution,sales and after-sales,procurement,facility and equipment,the number of defective items were 68,34,33,30,21,17,11 and 5.Conclusion Enterprises should establish a quality management system according to the requirements,and should have hardware conditions such as business place,warehouse,facility and equipment suitable for their drug business scope and business scale.A computer system should be adopted to ensure the traceability of the whole operation process.The on-site inspection of drug retail chain enterprises should focus on store management,shelf management,logistics distribution,pharmacist on-the-job management and so on.