Pharmaceutical Regulatory Inspections - Guide to Quality and Compliance - 2nd edition

Edited by Madhu Saghee, Tim Sandle and Gary Bird

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.

In over 500 pages and 14 chapters this book, unlike any other, brings together 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. There is even a chapter on virtual regulatory inspections which takes into account the ‘new normal’ of the pandemic age.

If you wish to ensure that your company will successfully pass the increasingly important regulatory inspections process, then this book is an essential item for your bookshelves.

The complete list of chapters and authors is as follows:

Chapter 1:  Basic concepts of global GMP requirements by Tim Sandle and Madhu Raju Saghee

Chapter 2:  FDA drug regulation and enforcement by Seth Mailhot

Chapter 3:  Responding to FDA: Clear directions by Gary Bird

Chapter 4:  Preparing for pre-approval Inspections by Ron Johnson

Chapter 5:  Effectively managing and surviving FDA inspections by John Avellanet

Chapter 6:  Guide for successful EU inspection management by Siegfried Schmitt

Chapter 7:  Regulatory requirements of Japanese GMP inspections by Yoshikazu Hayashi

Chapter 8:  Handling and responding to post inspectional observations by Tim Sandle, Madhu Raju Saghee and David Barr

Chapter 9:  Data integrity inspections: an overview by Tim Sandle, Madhu Raju Saghee and Gary Bird

Chapter 10:  Optimizing your regulatory compliance by Mark Tucker

Chapter 11:  Building an organisational quality culture by Ranjana Pathak

Chapter 12:  Preparing for regulatory inspections of sterile facilities: the focal points by Tim Sandle

Chapter 13:  Preparing for regulatory inspections of API facilities by Siegfried Schmitt

Chapter 14:  Virtual regulatory inspections: Part of the ‘new normal’ for pharmaceuticals and healthcare by Tim Sandle and Madhu Raju Saghee