Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success

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

MARTIN D. HYNES III is Director of Product Research and Development and Six Sigma Champion at Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana. Dr. Hynes has authored or co-authored numerous scientific articles, abstracts, book chapters, books, and patents. He is a member of a number of scientific and industry organizations. He has spoken and served as session chair at meetings of these organizations on numerous occasions. Dr. Hynes earned his bachelor’s degree in psychology from Providence College and his Ph.D. in pharmacology and toxicology from the University of Rhode Island. After completing a post-doctoral fellowship at the Roche Institute of Molecular Biology, he joined Lilly Research Labs. He has held several management positions, including Director of Pharmaceutical Project Management, Director of Quality Assurance, and Director for Clinical Research for Eli Lilly, Japan.