摘要
随着我国药品、医疗器械检验检测事业的迅猛发展及对药品、医疗器械质量要求的不断提高,对其相关标准物质的管理工作也倍受社会关注,本文论述了中检所标准物质管理体系成立后,对标准物质的管理模式,由原来的分散多头管理模式逐步向集中统一管理模式转变,对标准物质研制计划、标定方案和方法、质量控制、标定报告的技术审核和审批、制备、仓储和分发供应等进行全面有效的管理,基本实现了对中检所标准物质工作的整体把握和宏观管理。
With the rapid development of testing enterprise and continuous elevation of requirements for quality of drugs and medical devices in our country,the management of their relevant reference standards has been paid more close attention.This paper discussed the management mode of reference standards（RS） change from former multiple management gradually to centralized management after the establishment of RS management system of National Institute for the Control of Pharmaceutical and Biological Products（NICPBP）.The overall and effective RS management of development design,standardization program and method,quality control,technique examination and approvement of standardization report,preparation,reservation,distribution and supply,etc.realized global grasping and macroscopic management of RS work of NICPBP.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2010年第10期1993-1995,共3页
Chinese Journal of Pharmaceutical Analysis
关键词
药品
医疗器械
标准物质
集中管理
drugs
medical devices
reference standards（RS）
centralized management
