| 国际注册中的运输验证探讨 |
| |
| 引用本文： | 王建仕,丁恩峰,高海燕. 国际注册中的运输验证探讨[J]. 医药工程设计, 2014, 0(6): 60-64 |
| |
| 作者姓名： | 王建仕 丁恩峰 高海燕 |
| |
| 作者单位： | 石家庄龙泽制药有限公司;英国施达化学集团中国代表处;北京赛铭医药科技有限公司; |
| |
| 摘 要： | 随着中国2010版GMP的实施推进,以及国际药品贸易的广泛开展,如何保障药品在运输环节的质量稳定,成为国际注册和国际贸易的重要话题和关注热点。笔者长期跟踪研究药品国际认证和注册,以及药品运输过程中的稳定性,搜集并分析了关于运输环节药品质量保证的相关法规和指南,进行系统研究,提供药品企业借鉴。
|
| 关 键 词： | 稳定性 美国注射剂协会 运输验证 GMP 最差条件 GDP GSP |
Discussion of Validation for Transportation in International Registration |
| |
| Affiliation: | Wang Jianshi, Ding Enfeng, Gao Haiyan (1. Shijiazhuang Long Ze Pharmaceutical Co., Ltd, Shijiazhuang, 052560; 2. China Representative Office, Great Briton Shida Chemical Group Co., Shijiazhuang, 050031; 3. Beijing Spring PharmaTech lnc., Beijing, 100054) |
| |
| Abstract: | With the implementation of China＇s 2010 Edition GMP and wide extension of intemational drug trade, how to safeguard the stability of drug quality in transportation has been the important and widely concerned focus in international registration and trade. The writers have traced and studied international drug registration and trade and the issue of keeping the stability of drug quality in transportation for long time, the related codes and guides for ensuring drug quality in transportation were collected and analyzed. Thus, after systematic analysis, this article was fulfilled to provide references and helps for Chinese drug enterprises. |
| |
| Keywords: | Stability PDA transportation validation EU GMP Chinese GMP worst case GDP GSP |
| 本文献已被 CNKI 维普 等数据库收录！ |
|
