| 查看: 6451 | 回复: 109 | ||
| 当前只显示满足指定条件的回帖，点击这里查看本话题的所有回帖 | ||
[资源]
Validation of Active Pharmaceutical Ingredients, Second Edition
|
||
 Features Covers process validation, cleaning validation, quality assurance, technology transfer, microbial controls, biotechnology, and more Explains the relationship between GMP and validation and addresses how to validate correctly Describes in detail the FDA review process for Drug Master Files and the importance of keeping it current Discusses which systems are required to conform to GMP regulations Addresses change control programs and the possibility of a lack of adequate investigations Compares the validation process for APIs with the validation of drug products Delineates the validation process for APIs and compares Prospective Validation with Retrospective Validation Summary Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations. |
回复此楼» 本帖附件资源列表
-
欢迎监督和反馈：小木虫仅提供交流平台，不对该内容负责。
本内容由用户自主发布，如果其内容涉及到知识产权问题，其责任在于用户本人，如对版权有异议，请联系邮箱：xiaomuchong@tal.com - 附件 1 : Validation_of_Active_Pharmaceutical_Ingredients,_Second_Edition.pdf
2015-08-19 20:12:29, 15.83 M
» 本帖已获得的红花（最新10朵）
mkh520» 猜你喜欢
中文投稿“肿瘤免疫”相关
已经有6人回复
-
2025年药学专业求调剂
已经有1人回复
-
药理学论文润色/翻译怎么收费?
已经有123人回复
-
参比制剂，自己做的PK数据与IF资料报道的数据相差很大
已经有2人回复
-
祈求中本子
已经有0人回复
-
各位大佬，H口面上什么时候会评？？？
已经有30人回复
-
2026年山东大学海洋学院生物与医药博士招生-李霞课题组
已经有0人回复
-
博士研究生招生
已经有0人回复
-
药理学、临床药学方向 调剂
已经有1人回复
-
292药学调剂
已经有1人回复
-
这个自发加氧反应的机理是什么？
已经有7人回复
106楼2018-07-15 23:41:29
8楼2015-08-20 09:04:42
10楼2015-08-20 10:42:05
简单回复
pingshan2楼
2015-08-19 21:07
回复
五星好评 顶一下，感谢分享！
2015-08-20 08:05
回复
五星好评 顶一下，感谢分享！
2015-08-20 08:32
回复
五星好评 顶一下，感谢分享！
2015-08-20 08:34
回复
五星好评 顶一下，感谢分享！
taolubee6楼
2015-08-20 08:36
回复
五星好评 顶一下，感谢分享！
2015-08-20 08:47
回复
五星好评 顶一下，感谢分享！
2015-08-20 09:30
回复
五星好评 顶一下，感谢分享！
sunlong11楼
2015-08-20 11:27
回复
五星好评 顶一下，感谢分享！
plumty12楼
2015-08-20 11:29
回复
五星好评 顶一下，感谢分享！
aoying200813楼
2015-08-20 11:54
回复
五星好评 顶一下，感谢分享！
独叶一支枪14楼
2015-08-20 12:00
回复
五星好评 顶一下，感谢分享！
