药品技术转移过程中的知识管理探讨  

Discussion on Knowledge Management in Process of Drug Technology Transfer

作　　者：孙利民 赵震震 刘雪松 韩莹 SUN Li-min;ZHAO Zhen-zhen;LIU Xue-song;HAN Ying(Shandong Center for Food and Drug Evaluation and Inspection,Jinan 250013,China;Shandong Xinhua Pharmaceutical Co.,Ltd.,Zibo 255005,China)

机构地区：[1]山东省食品药品审评查验中心,山东济南250013 [2]山东新华制药股份有限公司,山东淄博255005

出　　处：《食品与药品》2024年第3期272-276,共5页Food and Drug

摘　　要：药品技术转移是药品生命周期中重要环节,技术转移的成功与否密切关系着药品的安全性、有效性和质量可控性,而知识转移是技术转移的核心。本文梳理了国内外药品知识管理相关指南要求,整理药品技术转移的常见问题,探讨技术转移过程中知识管理面临的挑战,为药品生产企业加强药品生命周期管理和提升药品质量提供参考。Drug technology transfer is an important link in the drug life cycle.The success of technology transfer is closely related to the safety,effectiveness and quality control of drugs,and knowledge transfer is the core of technology transfer.This paper reviews the relevant guidelines and requirements for drug-related knowledge management at home and abroad,sorts out the common problems of drug technology transfer,and discusses the challenges faced by knowledge management in the process of technology transfer,so as to provide references for drug manufacturers to strengthen drug life cycle management and improve drug quality.

关 键 词：技术转移 知识管理 隐性知识 质量管理 

分 类 号：TQ46[化学工程—制药化工] R95[医药卫生—药学]