thisdocumentrepresentsvoluntaryguidanceforthepharmac.docVIP

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 and country pharmaceutical excipient industry associations covering the United States, Europe, China and Japan (which are known respectively as IPEC-Americas, IPEC Europe, IPEC-China and Japan PEC). 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. IPEC has three major stakeholder groups; Excipient manufacturers and distributors, who are considered suppliers in this document, Pharmaceutical manufacturers, who are called users, and Regulatory authorities who regulate medicines. This document offers best practice and guidance in the establishment of a quality agreement between a buyer and a supplier of an excipient. The excipient supplier may be a manufacturer or a distributor (or both). The Guide highlights the factors to consider when planning and executing a such agreement between the parties.  ACKNOWLEDGEMENTS This guideline is the result of the hard work and substantial resources, of IPEC member companies. IPEC greatly appreciates the many hours the following individuals devoted to develop this guide and the generous support of their employers for providing the necessary time and resources. IPEC-AMERICAS Alexa Smith, Colorcon Priscilla Zawislak, Hercules Incorporated Craig Scott, JRS Pharma LP Laura Horne, Mutchler, Inc. David B. Klug, sanofi-aventis Maria Guazzaroni Jacobs, Pfizer Londa Ritchey, Wyeth Chris Armstrong, Evonik Judy Emmert, Abbott Ann Van Meter, Do