基于药品监管的广州市医疗器械第三方物流常见问题分析  

Analysis on Common Problems of Third-party Logistics Companies for Medical Equipment in Guangzhou

作　　者：何羡霞 姜志辉 李健 张强 He Xianxia;Jiang Zhihui;Li Jian;Zhang Qiang(Center for Certifi cation and Evaluation,Guangzhou Food and Drug Administration,Guangzhou 510140,China;Department of Pharmacy,General Hospital of Southern Theatre Command of PLA,Guangzhou 510010,China;Center of Medical Service and Training,General Hospital of Southern Theatre Command of PLA,Guangzhou 510010,China;Department of Procurement Management,General Hospital of Southern Theatre Command of PLA,Guangzhou 510010,China)

机构地区：[1]广州市食品药品监督管理局审评认证中心,广州510140 [2]中国人民解放军南部战区总医院药学部,广州510010 [3]中国人民解放军南部战区总医院卫勤训练中心,广州510010 [4]中国人民解放军南部战区总医院采购管理科,广州510010

出　　处：《中国药事》2022年第8期887-893,共7页Chinese Pharmaceutical Affairs

基　　金：广州市科技计划项目(编号201509010012)。

摘　　要：目的:通过对广州市22家医疗器械第三方物流企业的检查结果进行分析,指出第三方物流企业的优缺点,推进第三方物流企业更加规范发展。方法:以《广东省食品药品监督管理局医疗器械经营企业提供贮存、配送服务技术规定》为依据,对广州市医疗器械22家第三方物流企业的现场检查结果进行分类统计分析。结果:机构与人员方面出现缺陷项目29次;设施设备方面出现缺陷项目62次;计算机信息管理系统方面出现缺陷项目18次;质量管理制度及记录方面出现缺陷项目6次。结论:通过汇总广州市医疗器械第三方物流企业在检查过程中的常见问题,对企业提出针对性的建议,以供监管部门和物流企业相关人员进行参考。Objective: Through the analysis of the inspection results of 22 third-party logistics companies for medical equipment in Guangzhou, the advantages and disadvantages of third-party logistics companies were pointed out, and the more standardized development of third-party logistics companies was promoted. Methods:Based on the "Technical Regulations on the Provision of Storage and Distribution Services by Medical Device Operating Enterprises of Guangdong Food and Drug Administration", the on-site inspection results of 22 thirdparty logistics companies for medical devices in Guangzhou were classifi ed and analyzed. Results: There were 29 defective items in the organization and personnel, 62 defective items in the facilities and equipment, 18 defective items in the computer information management system, and 6 defective items in the quality management system and records. Conclusion: By summarizing the common problems in the inspection process of third-party logistics companies for medical devices in Guangzhou, targeted suggestions for the companies were provided, so as to provide references for supervisory departments and relevant personnel of logistics companies.

关 键 词：医疗器械 经营企业 第三方物流 现场检查 常见问题 

分 类 号：R95[医药卫生—药学]