Christopher Potter, PhD

ISPE CMC Pharmaceutical Consultant
Chris Potter graduated from the University of Exeter with a degree in chemistry and completed a PhD at Imperial College London University in organic chemistry. He started work at Beecham Research Laboratories, and moved to Sterling-Winthrop to take management positions in both pharmaceutical and analytical development. During this period he worked on both ethical and over-the-counter drug development. For the later period of his career, Potter moved to ICI Pharmaceuticals, later Zeneca, then AstraZeneca where he had a senior position as manager of Analytical Development and R&D QA and CMC Project Management Group with responsibility in both the UK and US. He finished his career as Director of External Pharmaceutical Programmes. Potter retired at the end of October 2007 and is now performing part-time CMC consultancy work. He is currently part time Technical Project Manager for ISPE's PQLI Program. Potter was a member of EFPIA's ad hoc Quality Group from 1996 to 2007, and during this period was EFPIA topic leader for ICHQ6A, Specifications for New Drug Substances and New Drug Products, and ICH Q4B, Regulatory Acceptance of Pharmacopoeial Interchangeability. Potter led EFPIA's PAT Topic Group, which produced a Mock P2 to promote discussion and understanding regarding how ICH topics Q8 and ICH Q9 could be implemented.

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ISPE Members Help Prepare Industry to Implement ICH Q9 Revision
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ISPE Members Help Prepare Industry to Implement ICH Q9 Revision

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)’s Quality Risk Management (QRM) guidance was signed off by ICH in November 2005 as one of a suite of guidelines alongside Q8, Pharmaceutical Development, Q10, Pharmaceutical Quality System and later, Q11, Development and Manufacture of Drug Substances, which describe the science- and...