A unique and comprehensive guide to ensure regulatory compliance and success in pharmaceutical regulatory inspections. In over 600 pages and twelve chapters this unique book provides a focussed account of regulatory issues from pre-approval inspections and the inspection itself to post inspection and maintaining compliance. This is a book that every pharmaceutical company will wish to study before and during any inspection process to ensure a successful outcome. Complete Remit - the book is a fully detailed and practical guide containing advice and insight to help any pharmaceutical organisation prepare for GMP Inspections, understand key regulatory issues and review inspectorate trends and findings. Expert advice - the authors, with a wealth of regulatory experience behind them, express their views and provide useful and practical tips for succeeding in vital regulatory inspections. International - the book includes chapters covering FDA Inspections, EU Inspections, Japanese Inspection and International Inspection processes.