知识管理在药品审核查验工作中的运用探讨  

Exploration of the Application of Knowledge Management to Drug Review and Inspection

作　　者：吴旭辰 张盈 许贤 王炜钦 陈鹭颖 WU Xu-chen;ZHANG Ying;XU Xian;WANG Wei-qin;CHEN Lu-ying(Center for Drug Inspection of Fujian;Department of Dietetics,Fujian Provincial Cancer Hospital)

机构地区：[1]福建省药品审核查验中心 [2]福建省肿瘤医院膳食科

出　　处：《中国食品药品监管》2025年第3期148-153,共6页China Food & Drug Administration Magazine

摘　　要：药品审核查验是依法对管理相对人从事药品研制、生产等场所、活动进行合规确认和风险研判的行为,需要药品检查员具备丰富的理论与实践知识。知识管理有助于提高药品审核查验效率,提升药品检查员队伍凝聚力。本文通过梳理知识管理概念,简要介绍国内外知识管理的发展和应用,并结合药品审核查验工作概况,探讨知识管理在药品审核查验工作中的运用,以期在提高药品检查员审核查验工作效率的同时,助力医药行业的发展。Drug review and inspection is the process of confirming compliance and conducting risk assessments on drug research and development and production activities carried out by regulated entities,as mandated by law.It requires drug inspectors to have extensive theoretical knowledge and practical experience.Knowledge management can improve the efficiency of drug review and inspection and enhance the cohesion of the inspector team.This article reviews the concept of knowledge management and briefly introduces its development and applications both domestically and internationally.By combining this with an overview of drug review and inspection work,the article explores how knowledge management can be applied to drug review and inspection,aiming to improve the efficiency of inspector work and contribute to the development of the pharmaceutical industry.

关 键 词：知识管理 审核查验 药品检查员 显性知识 隐性知识 

分 类 号：R95[医药卫生—药学]