Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 2

Sep 2019
PDA Item Number
Hardcover: 17354 | Digital: 18062
Member Price
Nonmember Price

Following an introduction to the subject of Good Distribution Practice (GDP), in the second volume, dive into supply-chain risk mitigation, serialization, and packaging as it relates to risk assessments.

This text and its companion Volume 1 will help drive down costs and improve efficiency.

Click here to order Volume 1

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

Foreword by Lea Joos

Section I Introduction

  1. Introduction by Siegfried Schmitt

Section 2 De-Risking the Supply Chain

  1. Risk Management and Supply Chain Security by Tony Pelli and Jim Yarbrough
  2. Prioritising and Managing Supply Chain Risks by Catherine Geyman
  3. Controlled Distribution Systems by Martine Zimmermann

Section 3 Serialisation and Packaging in Practice

  1. Serialisation - Preventing Falsification of Pharmaceutical Products by Fritz Roeder, Klaus Egner, Michael Hell
  2. Passive Packaging for the Temperature Controlled Transport of Healthcare Products by Stephen Brabbs, Srinivas Cherukupalli, Lawrence M. Knorr and Daniel Wisnom
  3. Active Unit Load Device Shipping Containers by Chris Fore
  4. Passive Thermal Packaging Solutions for Air Freight by Nicolas Buser
  5. Extractables and Leachables of Container and Packaging Systems for Pharmaceutical Products by Xiaochun Yu
  6. Serialisation Around the World by Wipotec-ocs

Section 4 Appendix

  1. Appendix Guide to Good Distribution Practice of Medicinal Products for Human Use by Health Products Regulatory Authority Ireland

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.