论疫苗监管质量管理体系在市县(区)药品监管部门的导入

Introduction of Quality Management System for Vaccine Regulation in Drug Regulatory Departments of Cities and Counties(Districts)

基于ISO 9001标准的质量管理体系在政府部门取得了一些实践经验,广东省市县(区)药品监管部门作出了建立疫苗监管质量管理体系的战略决策。本文介绍了广东省市县(区)药品监管部门导入疫苗监管质量管理体系的意义、思路和方法步骤,并基于导入过程中发现的主要问题提出解决对策,目的在于为市县(区)药品监管部门导入疫苗监管质量管理体系提供帮助。

Based on experience from implementation of the ISO 9001 quality management system in government departments,the city and county(district)drug regulatory departments in Guangdong province made the strategic decision to establish a vaccine regulatory quality management system.This paper introduces the significance,rationale and methods for incorporating the quality management system for vaccine regulation in drug regulatory departments of cities and counties(districts)in Guangdong province,and puts forward solutions for the main problems arising during the process,to support the introduction of quality management system for vaccine regulation in drug regulatory departments of cities and counties(districts).