摘要
目的:为药品零售企业经营许可换证现场检查提供参考,规范药品零售企业的经营行为。方法:统计厦门市2020—2022年申请经营许可换证检查的224家药品零售企业在现场检查中存在的缺陷项目,归纳分析药品零售企业换证现场检查中的常见问题,并提出措施和建议。结果:共发现缺陷项目1228次,其中严重缺陷项目1次,主要缺陷项目105次,一般缺陷项目1122次,在人员管理(36.24%)、销售管理(16.69%)、文件(13.19%)、采购与验收(10.75%)、陈列与储存(7.57%)和设施设备(7.33%)等方面存在问题。结论:药品零售企业应按照法律法规,结合企业,实际健全质量管理体系,加强人员培训管理、设施设备管理和经营全过程的管理;药品监督管理部门通过增加检查频次、加强智慧监管、提升检查员专业素质等方式提高监管效能,督促企业经营全过程持续符合法定要求。
Objective:To provide reference for drug distribution license renewal on-site inspection of drug retail enterprises and standardize the operation of drug retail enterprises.Methods:The defective items found in 224 on-site inspection reports of drug retail enterprises in Xiamen city between 2020 and 2022 were counted,the common problems found in the on-site inspection of drug retail enterprises were analyzed,and the measures and suggestions were put forward.Results:The total occurrence frequency of defective items found during the on-site inspection was 1228,including 1 serious defective item,105 main defective items and 1122 general defective items.The problems found in the inspection involving personnel management(36.24%),sales management(16.69%),document management(13.19%),procurement and acceptance(10.75%),display and storage(7.57%)and facility and equipment(7.33%).Conclusion:Drug retail enterprises should improve quality management system in accordance with laws and regulations and their actual situations,strengthen personnel training management,facility and equipment management and management of the whole business process.Drug regulatory departments improve regulatory efficiency by increasing the inspection frequency,promoting smart regulation and enhancing the professional quality of inspectors,and urge drug retail enterprises to continue to meet the legal requirements throughout the whole process of operation.
作者
张燕青
ZHANG Yanqing(Center for Food and Drug Evaluation&Certification&ADR Monitoring of Xiamen,Fujian Xiamen 361000,China)
出处
《中国医药导刊》
2023年第11期1100-1103,共4页
Chinese Journal of Medicinal Guide
关键词
药品零售企业
药品经营许可
现场检查
缺陷项目
Drug retail enterprises
Drug distribution license
On-site inspection
Defective items
