Автор: Martin D. Hynes
Название: Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, 2nd Edition
Издательство: CRC Press
Год: 2008
ISBN: 9780849391842; 0849391849
Серия: Drugs and the Pharmaceutical Sciences (Book 181)
Язык: English
Формат: pdf
Размер: 11,7 mb
Страниц: 304
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.