浅谈药品生产中的变更控制

Discussion on the change control in pharmaceutical production

现行GMP首次对变更控制管理作了要求,如何贯彻法规要求、建立有效的变更控制管理程序是企业必须面对的难题。通过阐述变更的基本概念、控制范围、分类和管理程序,希望为药品生产企业的变更控制管理提供参考。

For the first time, the current GMP requirements change control management.According to the new statute,how to establish the change control management Procedure is a problem that pharmaceutical enterprises faced.To elaborate the change basic conception, control range, class and management Procedure, in expectation, it will be referred for pharmaceutical enterprises.