摘要
目的浅析FDA对原料药的GMP现场检查。方法针对FDA关于原料药GMP现场检查的重点进行详细论述和分析。结果与结论企业如果建立了有效的GMP制度,那么企业完全能够通过FDA的认证。
Objective To provide an analysis of FDA inspection on GMP conformance for the manufacturing of active pharmaceutical ingredients （APIs）.Methods To carry out specific discussions and analysis focusing on FDA inspection on GMP conformance for the manufacturing of active pharmaceutical ingredients （APIs）. Results and Conclusion If enterprises have set up effective GMP system,an approval form FDA inspection would be safely assured.
出处
《中国药事》
CAS
2010年第9期917-918,共2页
Chinese Pharmaceutical Affairs
关键词
FDA
原料药
GMP现场检查
FDA
active pharmaceutical ingredients （APIs）
inspection on GMP conformance
