24小时热门版块排行榜

返回列表

【奖励】本帖被评价66次，作者1949stone增加金币 52.2 个

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

1949stone

荣誉版主 (知名作家)

应助: 95 (初中生)
贵宾: 2.38
金币: 3268.2
帖子: 9809
在线: 2692.1小时
虫号: 765987

[资源] PHARMACEUTICAL EQUIPMENT VALIDATION

FDA regulations, such as Current Good Manufacturing Practice (cGMP) for pharmaceuticals, Good
Laboratory Practice (GLP), Good Clinical Practice (GCP), and industry standard ISO 9000, require
that documentation, such as protocols, be established and followed. These regulations do not provide
guidelines on how specifically to produce the documentation. It is left up to individual companies
to design their own validation documentation system. This book provides hands-on
techniques for qualifying pharmaceutical equipment to achieve FDA compliance.
This book is designed for individuals responsible for writing and executing qualification protocols
for drug products and for related industries, such as drug devices and diagnostics, pharmaceutical
biotechnology, and bulk pharmaceutical chemicals. This book provides a complete set of
38 protocol templates. These templates are different because they are already filled in, thus providing
answers to many of your protocol writing and testing questions. Simple diagrams and other
graphics illustrate key ideas.
The author's personal experience with various regulators, such as FDA, FAA, NASA, and Explosives,
Firearms & Tobacco, influenced the decision to write this book. The need came from always
wanting to know exactly how to do something and the regulators' not providing it. The
methods described in this book are those of the author and are not to be construed as the policy
of his employer.
v

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 : Pharmaceutical_Equipment_Validation.pdf

2015-08-19 20:06:24, 7.02 M

1楼2015-08-19 20:06:34

已阅回复此楼关注TA 给TA发消息送TA红花 TA的回帖

相关版块跳转我要订阅楼主 1949stone 的主题更新

返回列表

24小时热门版块排行榜

1949stone

[资源] PHARMACEUTICAL EQUIPMENT VALIDATION

» 本帖附件资源列表

» 收录本帖的淘帖专辑推荐

» 猜你喜欢

» 本主题相关价值贴推荐，对您同样有帮助: