摘要
目的通过探讨欧盟GMP质量管理体系的构建,以增进国内制药行业对欧盟GMP认证的关注和相互借鉴,促进国内药品生产企业质量管理体系与国际药品管理标准接轨。方法介绍分析如何构建符合欧盟GMP药品质量管理体系,说明建立一个全面的质量管理体系对保证药品质量、获得欧盟认证的重要性,探讨如何构建符合欧盟GMP要求的药品质量管理体系,及其关键要素的理解和实际应用。结果与结论根据风险管理管理理念,重视偏差处理和变更控制,构建符合欧盟GMP要求的质量管理体系是提高国内药品质量管理水平的必由之路。
Objective By discussing the establishment of quality management system of European GMP,the essay is to enhance the attention of domestic drug maker for European GMP certificate and learning from the European regulations,and promote the quality system of domestic drug maker in line with international pharmaceutical management standards.Method The essay demonstrates how to establish the quality system compliance with European GMP as well as establishing a comprehensive quality system is important to guarantee the quality of drug and achieve European GMP certificate.The essay discusses how to establish a quality system in line with European GMP as well as the understanding and application of critical elements of quality system.Result and Conclusion Based on the concept of risk management, we should attach importance to deviation handling and change control. Establishing the quality system in line with European GMP is one of the best methods to improve the quality management of domestic drug makers.
出处
《首都医药》
2013年第16期11-13,共3页
Capital Medicine
关键词
欧盟GMP
质量管理体系
风险管理
European GMP
Quality Management System
Risk Management
