原料药USP认证与FDA认证区别探讨  

Discussion of Differences between USP Verification and FDA Inspection for API

作　　者：温艳华[1] 

机构地区：[1]浙江工业大学药学院研究生院,浙江杭州310014

出　　处：《医药工程设计》2007年第4期33-35,共3页Pharmaceutical Engineering Design

摘　　要：国内药企希望通过国际GMP认证以便将产品更快地推向国际市场,及时了解国际认证的最新动态非常必要。就新推出的USP药用成分认证和FDA认证的主要区别点作一探讨。The pharmaceutical enterprises hope to obtain international GMP certificate so as to push their products into international market more quickly. Therefore, it is necessary to learn the newest development of international verification. In this article, some differences between USP verification and FDA inspection were discussed.

关 键 词：原料药 USP认证 FDA认证 

分 类 号：F426.72[经济管理—产业经济]