Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1

Sep 2019
PDA Item Number
Hardcover: 17353 | Digital 18061
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Following an introduction to the subject of Good Distribution Practice (GDP), the first volume of this book covers key topics related to five main points: the applicable GDP regulations worldwide, including serialization; an overview of the requirements of Qualified Persons and Responsible Persons in GDP; GDP as part of the Quality Management System; an industry perspective on GDP; and a practical GDP checklist.

This text and its companion Volume 2 will help drive down costs and improve efficiency

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Table of Contents

Table of Contents:

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Foreword by Lea Joos

Section I Introduction

  1. Introduction by Siegfried Schmitt

Section 2 The Applicable GDP Regulations Globally, Including Serialisation

  1. Australia and New Zealand GDP Regulations by Clive Simon
  2. Good Supply Practices in China, Taiwan and Hong Kong by Yingying Liu
  3. Serialisation Regulations in the EU and the USA by Daniel Kavanagh
  4. Indian and Indonesian Serialization Regulations by Arjun Guha Thakurta and Timur Kabadayi
  5. GDP in Turkey by Mustafa Edik

Section 3 Qualified Person and Responsible Person in GDP

  1. The Role of the Qualified Person and Responsible Person in Good Distribution Practices by Blkash Chatterjee
  2. The Responsible Person — Role, Responsibilities and Experience from Practice by Bartosz Kaim

Section 4 GDP as Part of the Quality Management System

  1. Integrating Good Distribution Practice into the QMS by Tim Sandle
  2. Incoming Goods Management by Christian Gausepohl, Jurgen Ortlepp and Thomas Peither
  3. Developing GDP Knowledge and Skills by James Vesper
  4. Towards an Integrated Cold Chain by Alan Kennedy
  5. GDP Qualification of Contract Manufacturing Organizations by Frank Carroll

Section 5 Good Distribution Practice — The Industry Perspective

  1. Managing the Pharmaceutical Cold Chain by Steve Winyard
  2. Good Distribution Practice for Clinical Trial Materials by Andrea Zobel
  3. Qualification of Large-Scale Active Systems (Trailers) by Thomas Peither and Nicola Spiggelkotter
  4. Qualified Storage Design by Andrew Meyers
  5. Warehousing and Storage Qualification by Andrew Meyers

Section 6 Appendix

  1. Glossary
  2. GDP Checklist by Simone Ferrante and Thomas Peither

About the Authors

About the Editor

Dr Siegfried Schmitt, Vice President Technical at PAREXEL Consulting has 30 years' experience in the regulated healthcare industry. He has previously held positions in industry as Senior Production Chemist with Roche and global Quality Director with GE Healthcare and as Validation Manager with Raytheon and Senior Lead Consultant with ABB.

He has consulted with many clients on four continents, particularly on the design and operation of compliant, yet agile and effective quality systems.