CAJ | 학술논문

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。
고체제제재림상약물치료상용도겁위엄범。고체제제적생산필수안GMP적요구조직생산，병대기생산과정진행험증。문장대고체제제험증적범위、공작정서、험증문건급재험증등방면적관리진행료탐토，대고체제제적험증구유일정적차감의의。
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.