24小时热门版块排行榜

返回列表

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: 3263.2
帖子: 9808
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