Preparing for FDA Pre-Approval Inspections
A Guide To Regulatory Success, Second Edition
- Editore:
CRC Press
- EAN:
9780849391842
- ISBN:
0849391849
- Pagine:
- 304
- Formato:
- Hardback
- Lingua:
- Inglese
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Descrizione Preparing for FDA Pre-Approval Inspections
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
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