摘要
本文简要叙述了我厂化学原料药接受FDA检查的过程 ,对FDA检查中特别重视的几个GMP管理问题进行了深入分析 ,从而为完善原料药GMP管理 。
The procedure for FDA inspection bulk pharmaceutical chemicals (BPCs) is briefly instructed. Several queations for GMP management from FDA inspection are described. This article provide a reference for strengthening the GMP management and for promoting BPCs enter to US market.
出处
《中国药事》
CAS
2002年第12期745-747,共3页
Chinese Pharmaceutical Affairs
