Transcription of The IPEC Significant Change Guide for …
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The IPEC Significant Change Guide for …
Copyright 2014 The International pharmaceutical excipients Council The ipec Significant Change Guide for pharmaceutical excipients Third Revision 2014 Copyright 2014 The International pharmaceutical excipients Council Page 1 The ipec Significant Change Guide for pharmaceutical excipients (Third Revision, 2014) This document represents voluntary guidance for the pharmaceutical excipient industry and the contents should not be interpreted as regulatory requirements. Alternative approaches to those described in this Guide may be implemented FOREWORD International pharmaceutical excipients Council ( ipec ) is an international industry association formed in 1991 by manufacturers, distributors and end-users of excipients .
Copyright © 2014 The International Pharmaceutical Excipients Council Page 6 The underlying principle of the Guide is that all changes should be regarded as
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