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JOINT STEERING COMMITTEE Prof. Dr. Henk J de Jong Adrian Bone, B Pharm, MRPharmS Ashley McCraight, BSc, CChem, FRSC, MChem.A, MIQA Norman Randall, Ph.D., FRSC, CChem., FIQA Ashok V. Katdare, Ph.D R. Christian Moreton, B.Pharm., M.Sc., Ph.D., M.R.Pharm.S., M.Inst.Pkg.(Dip.), C.Sci.

CONSULTATION

During the preparation of this document we consulted with IPEC and PQG members, excipient and pharmaceutical companies, industry associations and regulatory agencies. Their critical and constructive comments made a significant contribution to the quality of this document.

IPEC and PQG would like to acknowledge the existing guidance and publications of the FDA, ICH, ISO and the WHO, which have been considered in the preparation of this Guide (see Bibliography).

DOCUMENT EDITING TEAM The following individuals spent many hours proof reading the document.

Alan Mercill Allan Whiston John Sullivan Brian Matthews Robert Haslam Sharon Shutler Irwin Silverstein Bill Hewlett Tim Dickinson Lyndsey Pearce Martin Dennison Kirit Sanghani John Swarbrick David McLean Adam Zaki Martine Powell

Secretary –Treasurer- IPEC-Americas Sanofi-aventis, PQG, IPEC-Europe Rephine Consultants Ltd, PQG, Alcon Laboratories, PQG Somerset House Consultants, PQG Protherics UK,PQG IPEC-Americas Johnson & Johnson, PQG 3M, PQG Astra Zeneca, PQG Seven Seas, PQG NHS, PQG Borculo Domo Ingredients, IPEC-Europe BSi, PQG Tablets2Buy, PQG Genzyme, PQG

Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group

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