山东省药品批发企业委托储运药品常见问题分析  

Analysis of common problems in drug storage and transportation entrusted by drug wholesale enterprises in shandong province

作　　者：谢纪珍 尚京迎 张莉 张娇 王群 XIE Jizhen;SHANG Jingying;ZHANG Li;ZHANG Jiao;WANG Qun(Shandong Center for Food and Drug Evaluation&Inspection,Jinan 250014,China)

机构地区：[1]山东省食品药品审评查验中心,山东济南250014

出　　处：《药学研究》2024年第7期718-722,共5页Journal of Pharmaceutical Research

摘　　要：目的分析山东省药品批发企业委托储存运输药品存在的问题,为监管部门科学监管与企业持续提升质量管理水平提出建议与对策。方法采用问卷调查、现场调研、分析检查数据等方法,分析山东省药品批发企业委托储存运输药品普遍存在的问题。结果山东省药品批发企业委托储存运输药品存在着一定的质量风险,主要集中在委托药品的质量管理、人员与培训、质量管理体系文件、计算机管理、药品运输管理等方面。结论国家有关部门需加强监督检查力度、建立药品现代物流服务体系并规范社会物流管理;企业在开展药品委托储存运输过程中应明确委托双方的主体责任、重视委托储存运输前的质量体系审计、加强信息化管理等。Objective This paper analyzes the problems existing in the storage and distribution of drugs entrusted by drug wholesale enterprises in Shandong Province,and puts forward suggestions and countermeasures for scientific supervision of regulatory departments and continuous improvement of quality management level of enterprises.Methods By using the methods of questionnaire,field investigation and analysis of inspection data,this paper analyzes the common problems of entrusted storage and distribution of drugs in drug wholesale enterprises in Shandong Province.Results There are certain quality risks in the entrusted storage and distribution of drugs by drug wholesale enterprises in Shandong Province,which mainly focus on the quality management of entrusted drugs,personnel and training,quality management system documents,computer management,drug transportation management and so on.Conclusion The relevant departments of the state should strengthen the supervision and inspection,establish the modern drug logistics service system and standardize the social logistics management;In the process of drug consignment storage and distribution,enterprises should clarify the main responsibilities of both parties,attach importance to the quality system audit before consignment storage and distribution,and strengthen information management.

关 键 词：药品批发企业 药品委托储运 质量风险 常见问题 对策思考 

分 类 号：R95[医药卫生—药学]