206x Filetype PDF File size 0.18 MB Source: ipecamericas.org
INTERNATIONAL PHARMACEUTICAL EXCIPIENT COUNCIL GLOSSARY Purpose This document is to be used as a reference to understanding the meaning and uses of the vocabulary in the IPEC guidance documents and papers. It should help facilitate better understanding in he interpretation of the intent and applications of the expectations conveyed. Scope The contents of this document cover current documents and papers generated by IPEC organizations. It should be used as a reference in writing future documents and as a bridge to current GMP thinking as technology and requirements change. Layout The Glossary uses the typical layout of being alphabetized with acrynoms and terms. Terms or words used in current IPEC documents are reference to the document(s) in which they are used following each entry. A Reference Guide is listed at the end of the glossary. 1 INTERNATIONAL PHARMACEUTICAL EXCIPIENT COUNCIL Glossary of Official Definitions for Excipients 2010 2 INTERNATIONAL PHARMACEUTICAL EXCIPIENT COUNCIL OFFICIAL GLOSSARY 2010 3 Acknowledgements This document was created by representatives of the many member companies of the International Pharmaceutical Excipients Council of the Americas. It is a compilation of the glossaries taken from the various guidance documents and papers generated by IPEC organizations within the IPEC Federation which is the global IPEC Organization. The writing of future guidance documents will be aligned with the volcabulary in this document and this document will be revised as technology and terminology demand. This Glossary is intended to aid in understanding the terminology of the language used in IPEC Guidance Documents. The terms used in the guidances and papers produced by IPEC should be interpreted by the definitions and explanations and should be consistent in interpretation across documents. It is our attempt to streamline and come in harmony with the language of the Pharmaceutical and Food industries. This will allow producers and users of the products marketed by these industries to have a common understanding when communicating expectations and requirements. 4
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