Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production (single user digital version)

Table of Contents:

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1. Introduction by Trevor Deeks
2. What is Phase Appropriate GMP? The Regulatory Background and Current Expectations by Trevor Deeks
3. Impact of the EU Clinical Trials Directive and the Role of the QP by Mark Slattery
4. Systems and System Integrity in the Analytical Laboratory by Siegfried Schmitt
5. Phase Appropriate GMP in the Laboratory by John Duguid
6. Phase-Based Approach to Quality Assurance in Pharmaceutical Manufacturing — Big Pharma Perspective by David Grote
7. Phase Appropriate cGMPs: The Virtual Company by Paul Steiner and Trevor Deeks
8. Deviations, Change Control, Process Improvements by Sue Schniepp
9. Creating a Culture and System for Learning when using a Phase Appropriate Model by James Vesper
10. Cell Line Characterization by Sandra K. Dusing, Kathy Martin Remington, Marian L. McKee, and Audrey Chang
11. Considerations for Viral Clearance Studies by Kathryn Martin Remington and Kate Smith
12. The Impact of Single-use Systems on the Application of Phase Appropriate GMP in Bioprocessing by Trevor Deeks and Jeff Blake
13. Regenerative Medicine Advanced Therapies: Phase Appropriate Good Manufacturing Practices by Gary C. du Moulin
14. Microbiological Control and Testing for Phase Appropriate GMP by Tim Sandle
15. The Evolution of Process Validation by Karen Zink McCullough
16. Sterility Assurance in Early Phase Development by Tim Sandle

About the Author

Trevor Deeks, Ph.D. has 38 years of experience in pharmaceutical development, manufacturing, quality control and quality assurance. He is registered as an eligible QP under EC Directive and has also practiced as a registered Pharmacist in the UK. He now resides in Maryland and has his own consulting business. He has a Ph.D. in Peptide Chemistry and has extensive expertise in aseptic processing and a wide range of unique and unusual biotechnology processes, including live vaccines, tissue culture products, and cellbased products, working with many of the top 20 Global Pharma and Biopharma companies. He has held a number of senior management positions in Quality and in Process and Analytical Development.

He has practiced as a QP since 1983 and his QP experience includes commercial batch release, investigational medicinal products and "Specials". He has established and operated Quality Systems in compliance with the European Clinical Trials Directive and with global regulatory expectations (FDA, WHO, ANVISA, etc.). He has led scale-up and technology transfer projects for large and small molecules, has managed many projects with contract manufacturing organizations, has undertaken a number of evaluations of new technologies, and has performed due diligence evaluations of such products for acquisition.