ISBN 978-1-899015-89-4 (Hb); ISBN 978-0-9573491-3-1 (Pb)
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 postinspection 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.
"The book is timely, relevant and important… it contains chapters written by a number of international experts and covers everything anyone could possibly wish to know about the inspection process and quality issues affecting pharmaceuticals and healthcare… it also covers the key points that are likely to arise during an inspection or audit. This includes documentation, electronic systems, staff training, hygiene, licencing, compliance and so forth. The quality of the explanations is high and the book is packed full of useful examples and case studies… It is an unique book… an essential item for the book shelf of anyone involved with quality inspections, audits or GMP."
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.
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.
The book includes chapters covering FDA Inspections, EU Inspections, Japanese Inspection and International Inspection processes.
1 Basic Concepts of Global GMP Requirements
by Tim Sandle and Madhu Raju Saghee
2 FDA Drug Regulation and Enforcement
by Seth Mailhot
3 System Based Approach to Inspections
by David Barr and Tim Sandle
4 Preparing for Preapproval Inspections
by Ron Johnson
5 Effectively Managing and Surviving FDA Inspections
by John Avellanet
6 Guide for Successful EU Inspection Management
by Siegfried Schmitt and Nabila Nazir
7 Regulatory Requirements of Japanese GMP Inspections
by Yoshikazu Hayashi
8 Preparing and Management of International Inspections
by Andreas Brutsche and Tim Sandle
9 Handling and Responding to Post Inspectional Observations
by Tim Sandle, Madhu Raju Saghee and David Barr
10 Preparing for Regulatory Inspections of Sterile Facilities: The Focal Points
by Tim Sandle
11 Preparing for Regulatory Inspections of API Facilities: The Focal Points
by Siegfried Schmitt and Richard Einig
12 Optimizing your Regulatory Compliance
by Mark Tucker