Pharmaceutical Pre Approval Inspections A Guide to Regulatory Success 2nd Edition by Martin D Hynes III ISBN 0849391849 9780849391842

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Product details:

ISBN 10: 0849391849

ISBN 13: 9780849391842 

Author:  Martin D. Hynes III 

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

Table of contents:

1. Introduction/Preface
2. Pre-Approval Inspection: A Historical Overview
3. Recent Trends in Domestic and International Pre-Approval Inspections
4. The Implications of the Quality Systems, Risk Based Inspections and 21st Century GMPs to Preparing for FDA Pre-Approval Inspections
5. Preparing for FDA Pre-Approval Inspections
6. Similarities and Differences between Center for Biologics Evaluation and Research (CBER) / Center for Drug Evaluation and Research (CDER)
7. The GMP Risk Assessment
8. Guidance for Preparing for Pre-Approval Inspections, Traditional and Non-Traditional
9. The Product Development Drill
10. The Importance of Good Science, Stability Data, Scale Up, and Validation to Successfully Passing a Pre-Approval Inspection
11. The History of Development Documents: Guidance for Preparation in Light of Recent Trends
12. Computer Validation
13. Systems Validation during the Drug Development Process
14. The Use of Audits during the Drug Development Process to Assure a Successful Pre-Approval Inspection
15. The Consequence of a Poor Product Development Process and Failing a Pre-Approval Inspection

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Tags: Martin D Hynes III, Pharmaceutical Pre Approval Inspections, Guide, Regulatory Success