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IPEC EXCIPIENT INFORMATION PACKAGE (EIP): …
ipec EXCIPIENT INFORMATION PACKAGE (EIP): TEMPLATE AND USER GUIDE 2009 Copyright 2009 The International Pharmaceutical Excipients Council 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 ipec is an international industry association formed in 1991 by manufacturers and end-users of excipients. It is an association comprising four regional pharmaceutical EXCIPIENT industry associations covering North America, Europe, China and Japan (which are known respectively as ipec -Americas, ipec Europe, ipec -China and JPEC). 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.
SECTION BY SECTION EVALUATION OF THE EXCIPIENT INFORMATION DOCUMENTS I. Product Regulatory Datasheet The Product Regulatory Datasheet is designed as a means to assist in communicating to
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