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The IPEC Risk Assessment Guide for …
The IPEC Risk Assessment Guide for pharmaceutical excipients Part 1 Risk Assessment for Excipient Manufacturers First Version 2017 2014 Copyright 2017 The International pharmaceutical excipients Council Page 2 of 43 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 . At the time of writing there are regional pharmaceutical excipient industry associations including the Americas, Europe, Japan, China, and India. IPEC s objective is to contribute to the development and harmonization of international excipient standards, the introduction of useful new excipients to the marketplace, and the development of best practice and guidance concerning excipients .
The IPEC Risk Assessment Guide for Pharmaceutical Excipients Part 1 – Risk Assessment for Excipient Manufacturers First Version 2017 2014
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