浅谈FDA以风险为基础的药品生产检查方法及启示

FDA's Risk-based Inspections Approach for Pharmaceutical Manufacturers and It's Enlightenments

介绍美国食品与药品管理局(FDA)推行的以风险为基础的药品生产检查方法,并探讨其对我国实施GMP的启示。FDA以风险为基础的检查方法中引入了风险的概念和质量系统模型,从中我们可以认识到在GMP实施过程中应当引入一种以风险为基础的检查方法,整合质量系统,加强对生产过程的重视程度,注重企业管理层的领导支持。

The thesis introduces FDA＇s risk- based inspections approach for pharmaceutical manufacturers, and discusses its enlightenment for GMP implementations in China. FDA＇s risk-based approach integrated the concept of risk and a quality-system model, from which we can realize that we should bring in a risk-based approach in GMP implementations, integrate quality systems, pay more attention to manufacturing process, and attach importance to support of leadership.