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IPEC Europe

Supporting the interests of pharmaceutical excipient developers, producers, distributors and users.

Guidelines

IPEC Guidelines


The IPEC guidelines can be downloaded here:

 

2016 The IPEC Europe 'How-To' Document on EU Guidelines on Risk Assessment for Excipients

> Download PDF Format

 

2014 The IPEC Glossary of Terms

> Download PDF Format

 

2014 The IPEC Significant Change Guide, third revision:

> Download PDF Format

 

2013 The IPEC Certificate of Analysis Guide

> Download PDF Format

 

2012 The IPEC Excipient Information Package (EIP): Template & User guide

> Download Word format
> Download PDF format 

 

2010 The IPEC Excipient Stability Program Guide

> Download PDF format

 

2009  The IPEC Excipient Composition Guide

> Download PDF format

  

2009 The IPEC Quality Agreement Guide & Template

> Download Word format
> Download PDF format

 

2008 Qualification of Excipient for Pharmaceutical Use

> Download Word format
> Download PDF format

 

2008 The IPEC-PQG Good Manufacturing Practices Audit Guideline

> Download Word format
> Download PDF format

 

2006 The IPEC-PQG Good Manufacturing Practices Guideline

> Download PDF format

 

2011 The IPEC Good Distribution Practices Audit Guideline

> Download Word format
> Download PDF format

 

2006 The IPEC Good Distribution Practices Guideline

> Download PDF format

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