化学合成原料药生产工艺中溶剂回收的GMP相关要求  

The GMP requirements of solvent recovery in synthetic drug substances production

作　　者：王宏亮 WANG Hong-liang(Center for Drug Evaluation,National Medical Products Administration,Beijing100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2022年第20期1997-2000,共4页Chinese Journal of New Drugs

摘　　要：溶剂回收是原料药生产工艺中常见的步骤之一,为了保证原料药的质量,回收溶剂应符合相应的要求。基于此,本文对ICH,WHO,美国FDA,欧洲EMA及国内溶剂回收的相关要求进行深入的剖析,为业界提供参考和借鉴。Solvent recovery is one of the common steps in manufacturing process of drug substance. In order to guarantee the quality of drug substance, solvent recovery should meet the related GMP requirements. Based on this, aiming to provide a reference for the industry development, this article summarizes ICH, WHO, FDA, EMA and related domestic requirements of solvent recovery.

关 键 词：原料药 溶剂回收 回收溶剂 指导原则 

分 类 号：R95[医药卫生—药学]