中国食品药品监管Issue(4)：124-131,8.DOI:10.3969/j.issn.1673-5390.2025.04.012
药品批发企业冷链验证关键控制点研究及对策
Research and Countermeasures on Key Control Points in Cold Chain Validation for Pharmaceutical Wholesale Enterprises
赵彩虹 1邹辉 2侯玉磊 1郭春彬 1张莉 1田宝坤 1张敬涛 1李海峰1
作者信息
- 1. 山东省食品药品审评查验中心
- 2. 山东大舜医药物流有限公司
- 折叠
摘要
Abstract
To promote the standardized and regulated implementation of validation for cold-chain drug storage and transportation facilities,and to ensure the safety of cold-chain pharmaceuticals,this paper focuses on the key control points and common issues encountered during verification processes in pharmaceutical wholesale enterprise.Based on the Good Supply Practice for Drug,combined with requirements from drug regulatory authorities,real-world practices in enterprises,third-party supplier audit standards,and prevailing industry consensus,the study analyzes current challenges,areas of controversy,and underlying causes from three perspectives.The results indicate shortcomings in the professional knowledge of validation personnel,inconsistencies in validation standards and references,and insufficient accountability among third-party validation agencies.Therefore,regulatory authorities and wholesale enterprises should fulfill their supervisory and primary responsibilities,enhance the legal and standard framework related to cold chain validation,strengthen professional training and management,and ensure drug quality and safety during storage and transportation processes.关键词
药品/冷链验证/冷链药品储运/关键控制点/对策Key words
pharmaceuticals/cold chain validation/cold chain drug storage and transportation/key control points/countermeasures分类
医药卫生引用本文复制引用
赵彩虹,邹辉,侯玉磊,郭春彬,张莉,田宝坤,张敬涛,李海峰..药品批发企业冷链验证关键控制点研究及对策[J].中国食品药品监管,2025,(4):124-131,8.
