摘要
药品检查工作是药品监督管理工作的重要组成部分,在药品监管中具有无可替代的作用。药品检查机构是否建立完备且可操作的质量管理体系,对药品检查工作的质量起关键作用。本文总结了国内外药品检查机构质量管理体系建设发展历程及近些年的研究进展,并提出了完善我国药品检查机构质量管理体系的对策。
Drug inspection work is an important component of drug supervision and management,and plays an irreplaceable role in drug supervision.The establishment of a complete and operable quality management system by drug inspection institutions plays a crucial role in the quality of drug inspection work.This article summarizes the development process and research progress of the quality management system construction of domestic and foreign drug inspection institutions in recent years,and proposes countermeasures to improve the quality management system of China's drug inspection institutions.
作者
喻文进
涂司武
葛涛
梅俊俊
江亚明
黄伟波
周宇星
Yu Wenjin;Tu Siwu;Ge Tao;Mei Junjun;Jiang Yaming;Huang Weibo;Zhou Yuxing(Jiangxi Drug Inspection Center,Nanchang 330001,China)
出处
《广东化工》
CAS
2023年第21期66-67,57,共3页
Guangdong Chemical Industry
基金
江西省药品监督管理局科研项目(2022GL13)。
关键词
药品检查机构
质量管理体系
研究进展
drug inspection institutions
quality management system
research progress
