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GAMP
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Good Practice Guide: Page 3
A Risk-Based Approach to GxP Process Control Systems
Acknowledgements
The following Task Team, and members of the ISPE GAMP Community of Practice (COP) Process Control Special
Interest Group (SIG), worked on one or more of the sections of this document and volunteered their knowledge,
practical experience and precious time to provide input material, attend meetings and review the multiple drafts.
Task Team Leader/SIG Chair:
Mark Cherry AstraZeneca United Kingdom
Task Team Co-Leader/SIG Deputy Chair:
Hilary Mills-Baker WSP CEL Ltd. United Kingdom
GAMP Council Sponsor:
Guy Wingate GlaxoSmithKline United Kingdom
Special Interest Group Team:
Karen Ashworth Karen Ashworth Consulting Ltd. United Kingdom
Roger Buchanan Eli Lilly & Co. Ltd. United Kingdom
Reetu Chopra Teva Pharmaceuticals United Kingdom
Peter Falcon AstraZeneca United Kingdom
David James Invensys System (UK) Ltd. United Kingdom
Peter Iles-Smith GlaxoSmithKline United Kingdom
Martin Isherwood Eli Lilly & Co. Ltd. United Kingdom
Malcolm Knott Industrial Technology Systems Ltd. United Kingdom
Walfraid Laibacher Honeywell Building Solutions GmbH Germany
Brian Nolan Organon Ireland Ltd. Ireland
Blaise Polentes Sano-Aventis R&D USA
Bo Reedtz Denmark
George Smerdon Industrial Technology Systems Ltd. United Kingdom
Sue Tuxford Emerson Process Management United Kingdom
Rainer Van Deursen Eurotherm Deutschland GmbH Germany
Gerhard Werling Rockwell Automation Solutions GmbH Germany
The Task Team would like to acknowledge the support of their direct management and companies in this endeavor.
The Task Team leaders would like to express their thanks to the following for their contribution of additional materials
and as technical reviewers of the Guide:
John Robert (Bob) Adamson* RBQ Services Limited United Kingdom
John Berridge ISPE European Regulatory Affairs Advisor United Kingdom
Joerg Block Bayer HealthCare AG Germany
Winnie Cappucci Bayer HealthCare USA
Waunetka A. Clark Abbott Laboratories USA
Sandro De Caris GAMP Italiano / Consultant Italy
Rick Gunyon* Eli Lilly and Co. USA
Justin Iovino Cognizant Technology Solutions USA
Jim John ProPharma Group / JETT SIG of GAMP Americas USA
Richard Lemire Novartis Pharmaceuticals Corporation USA
Tony Margetts Factorytalk Co. Ltd. Thailand
Dr. Arthur (Randy) Perez Novartis Pharmaceuticals Corporation USA
Gregory Ruklic Independent Life Sciences Professional USA
Tulsa Scott* Commissioning Agents USA
Jennifer Thompson ABB (now of Durham University) United Kingdom
*Member of the ISPE Commissioning & Qualication Community of Practice (C&Q COP)
For individual use only. © Copyright ISPE 2011. All rights reserved.
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