GMP Spezial

This book serves as a comprehensive overview and guide to the technology transfer process for pharmaceutical drug substance and products and the corresponding analytical methods and tests from R&D to production. Each of the contributors has extensive personal knowledge and experience in this field and each has provided practical examples to explain the critical factors involved in achieving successful and effective technology transfers.

This book will benefit practitioners working in the pharmaceutical science and related industries from R&D, commercial production to project management, clinical, regulatory affairs and quality assurance.

Technology Transfer will lead the reader through all of these issues to help you successfully navigate the waters of technology transfers to mitigate delays in product registration and loss and alleviate the risk of adding to the already huge cost of getting a new product to market.

Table of Contents:
1. Technology Transfer Introduction and Objectives by Mark Gibson
2. Technology Transfer: The Regulatory and Business Perspective by Alan Harris and Siegfried Schmitt
3. Technology Transfer: Organisation Strategy and Planning 25 by Steve Burns and Mark Gibson
4. Training: An Essential Element of Technology Transfer by Siegfried Schmitt
5. Drug Substance Development and Technology Transfer by Alan Harris
6. Drug Product Development and Technology Transfer by Mark Gibson
7. Analytical Methodology and Specifications by Kevin McKiernan and Mark Hindle
8. Pre-Approval Inspection and Launch by Mark Gibson
Glossary of Common Terms, Abbreviations and Acronyms
Author Biographies
Index
List of Tables
List of Figures

Dr. Mark Gibson is responsible for pharmaceutical development of new chemical entities and new product opportunities, including clinical trial manufacture, technology transfer to production and support to marketed products at AstraZeneca R&D Charnwood, a division of AstraZeneca. He received his degree and PhD in pharmacy from Bradford University and Bath University in the U.K., respectively. He has over 20 years of experience of working in the pharmaceutical industry in R&D both as a bench scientist and a manager, at Cyanamid UK (Lederle), Fisons Pharmaceuticals, Astra Pharmaceuticals and AstraZeneca. He has worked on a variety of dosage forms and routes of delivery including oral, inhalation, nasal, ophthalmic, parenteral and transdermal, some of which have resulted in patents and successful technology transfer from R&D to different production sites around the world. He has also experience of working within different technology transfer operational guidelines and of giving seminars and presentations on product development and technology transfer. He has edited a book on Pharmaceutical Preformulation and Formulation published in 2001 by Interpharm (now Taylor & Francis) and a book on Technology Transfer published by PDA in 2005. Dr Gibson is a member of the Royal Pharmaceutical Society of Great Britain, the Royal Society of Chemistry (Chartered Chemist), UK Academy of Pharmaceutical Sciences, the U.K. Parenteral Society and the American Association of Pharmaceutical Scientists.

PDA/DHI Publication