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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.
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