Pharmaceutical Regulatory Inspections - 2nd Edition
Edited by Madhu Raju Saghee
This book contains practical advice and insight to help different types of pharmaceutical organisations prepare for GMP inspections, understand key regulatory issues and review inspectorate trends and findings. The book compares inspections by the major regulatory agencies, the FDA, EU and Japan, as well as international inspections.
This is a unique book in which agency inspectors and seasoned industry experts express their views and provide advice and tips on how to successfully pass regulatory inspections.
No other book captures such a diverse range of experts to provide a focussed account of regulatory issues from pre-approval inspections and the inspection itself to post-inspection and maintaining sustainable compliance.