Pharmaceutical for Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition by Martin D. Hynes
Pharmaceutical for Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition by Martin D. Hynes
English | March 5, 2008 | ISBN: 0849391849 | 304 pages | PDF | 9,5 MB
English | March 5, 2008 | ISBN: 0849391849 | 304 pages | PDF | 9,5 MB
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
[[/b] Rss Channel ] / [[/b] Mein Blog ]
![Pharmaceutical for Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition by Martin D. Hynes]()
Pharmaceutical for Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition by Martin D. Hynes
