基于合规要求探讨药品批发企业不合格药品退货及处置策略  

Discussion on Return and Disposal Strategy of Unqualified Drugs in Drug Wholesale Enterprises Based on Compliance

作　　者：张艳 邢倩 侯玉磊 李海峰 王帅 谢纪珍 ZHANG Yan;XING Qian;HOU Yu-lei;LI Hai-feng;WANG Shuai;XIE Ji-zhen(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：《食品与药品》2024年第5期479-480,I0004,I0005,共4页Food and Drug

摘　　要：药品批发企业实际经营过程中,不合格药品的退货及处置对企业药品质量管理体系和合规要求提出挑战,本文通过分析不合格药品分类、不合格药品产生原因及法规要求,对不同情况的不合格药品退货处置提出相应建议,最大程度地降低药品在流通过程中的风险隐患,提高药品批发企业质量管理效率,助力医药流通行业高质量健康发展。In the actual operation process of pharmaceutical wholesale enterprises,the return and disposal of unqualified drugs challenge the drug quality management system and compliance requirements of the enterprises.By analyzing the classification of the unqualified drugs,the causes of and the regulatory requirements of the unqualified drugs,this paper puts forward corresponding suggestions on the return and disposal of the unqualified drugs in different situations,so as to minimize the potential risks of drugs in the circulation process,improve the quality management efficiency of the drug wholesale enterprises,and promote the high-quality and healthy development of the pharmaceutical circulation industry.

关 键 词：药品批发企业 不合格药品 药品退货及处置 合规要求 

分 类 号：R95[医药卫生—药学]