制药企业质量管理体系中纠正与预防措施(CAPA)的实施

The Implementation of Corrective and Preventive Action in Pharmaceutical Companies′ Quality Management System

纠正与预防措施(CAPA)作为质量管理体系的重要组成部分,我国即将颁布的新版GMP也明确了建立CAPA体系的要求。本文从制药企业的角度详细讨论了CAPA的实施步骤,从而提高企业的质量管理水平。

Corrective and preventive action （CAPA） as an important part of quality management system.It is also required to be established in newly GMP of China.This paper write about the implementation steps of CAPA from the view of pharmaceutical companies,to improve the quality of enterprise management level.