GMP中间体生产厂房验证URS的编写要点  

The Main Points of Compiling User Requirement Specification for GMP Intermediate Premises Validation

作　　者：杨睿雅 梁毅[1] Yang Rui-ya;Liang Yi

机构地区：[1]中国药科大学国际医药商学院,江苏南京211198

出　　处：《化工设计通讯》2021年第8期189-191,共3页Chemical Engineering Design Communications

摘　　要：基于GMP中间体生产的特殊性,着重从GMP角度对GMP中间体生产厂房验证URS的编写进行探讨,以指导GMP中间体生产企业开展工作,保障最终原料药的质量。Based on the particularity of the manufacturing of GMP intermediate,the preparation of user requirement specification for GMP intermediate premises validation is discussed from the perspective of GMP to guide GMP intermediate manufacturers to carry out their work and ensure the quality of the final active pharmaceutical ingredients.

关 键 词：GMP中间体 生产 厂房验证 用户需求说明 

分 类 号：F426.72[经济管理—产业经济]