Preparing for FDA Pre-Approval Inspections —— A Guide to Regulatory Success, Second Edition

----- 药剂预先核准检查：调整成功指南

ISBN: 9780849391842 出版年：2016 页码：306 CRC Press

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. Th