| 原料药USP认证与FDA认证区别探讨 |
| |
| 引用本文： | 温艳华. 原料药USP认证与FDA认证区别探讨[J]. 医药工程设计, 2007, 28(4): 33-35 |
| |
| 作者姓名： | 温艳华 |
| |
| 作者单位： | 浙江工业大学药学院研究生院,浙江杭州,310014 |
| |
| 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。
|
| 关 键 词： | 原料药 USP认证 FDA认证 |
| 文章编号： | 1008-455X（2007）04-0033-03 |
| 修稿时间： | 2007-02-28 |
Discussion of Differences between USP Verification and FDA Inspection for API |
| |
| Wen Yanhua. Discussion of Differences between USP Verification and FDA Inspection for API[J]. Pharmaceutical Engineering Design, 2007, 28(4): 33-35 |
| |
| Authors: | Wen Yanhua |
| |
| Affiliation: | Zhejiang University of Technology, Hangzhou, 310014 |
| |
| Abstract: | 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. |
| |
| Keywords: | API USP certification FDA inspection |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ |
