This Guide was prepared by a team from The International Pharmaceutical Excipients Council (IPEC) and the Pharmaceutical Quality Group (PQG).
IPEC is an international industry association formed in 1991 by manufacturers and end-users of excipients. It is an association comprising three regional pharmaceutical excipient industry associations covering the United States, Europe and Japan (which are known respectively as IPEC-Americas, IPEC Europe and JPEC). IPEC’s objective is to contribute to the development and harmonisation of international excipient standards, the introduction of useful new excipients to the marketplace and the development of good manufacturing practice for excipients.
IPEC first published its GMP Guide for Bulk Pharmaceutical Excipients in 1995 and it was revised in 2001 to align it with ISO 9001:2000.
For further information see www.ipec.org
The PQG was formed in 1977 to promote development of a consistent approach to pharmaceutical quality and good manufacturing practice. The group has since expanded, and in 1990 the PQG published three codes of practice to cover pharmaceutical raw materials, printed and contact packaging materials. In 1995 the codes were revised and were integrated with ISO 9002:1994. The code for raw materials was revised and reissued as PS 9100:2002 Pharmaceutical excipients, an application standard and GMP guide for pharmaceutical excipients.
For further information see www.pqg.org
IPEC and PQG greatly appreciate and acknowledge the many hours of hard work the following individuals devoted to creating this Guide and the generous support provided by their employers:
CORE REVISION TEAM IPEC-AMERICAS
Sidney A. Goode, Pharm D., RPh., The Dow Chemical Company. Rodney J. H. Gray, PhD., Hercules Incorporated.
Kevin McGlue CSci, CChem, MRSC, Colorcon Patricia Rafidison, RPh., Ph.D., Dow Corning
Stephen Moss Ph.D., MBA, CChem, FRSC, MIQA, GlaxoSmithKline Iain Moore, Ph.D., CChem, MRSC, MIQA, Croda Chemicals Europe Ltd.
In addition, IPEC-PQG would also like to express its thanks to the management of Colorcon and GSK for the use of their resources and premises.
Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group