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Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition. 2nd edition
・ISBN 978-0-367-45271-1 paper GB£ 68.99
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| 著者・編者 | Hynes, Martin D. (ed.), |
|---|---|
| 出版社 | (CRC Press, UK) |
| 出版年月 | 2019 |
| ページ数 | 304 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A00-49535＞ |
解説
This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval.
Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition:
- chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections
- demonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors
- focuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility