浅谈固体制剂的验证管理

Introduction to Validation Management of Solid Preparation

固体制剂在临床药物治疗上用途极为广泛。固体制剂的生产必须按GMP的要求组织生产,并对其生产过程进行验证。文章对固体制剂验证的范围、工作程序、验证文件及再验证等方面的管理进行了探讨,对固体制剂的验证具有一定的借鉴意义。

Solid preparation in clinical drug treatment is widely. Solid preparation production must be produced according to the requirement of GMP organization, and its production process verification, In this paper, the solid preparation verification scope, procedures, and validation file and revalidation management are discussed,which has a certain reference significance to verify the solid preparation.