IPEQ - The International Pharmaceutical Excipients Council

Know and download the current Good Manufacturing Practice guidelines developed by The International Pharmaceutical Excipients Council
IPEC Europe, the International Pharmaceutical Excipients Council Europe, is an association that serves the interests of producers, distributors and users of pharmaceutical excipients. Together with its sister associations, IPEC Americas and IPEC Japan (JPEC), the Council is a member of IPEC Federation whose global membership extends to more than 200 companies.

The IPEC guidelines can be downloaded here:
2014 The IPEC Glossary of Terms
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2014 The IPEC Significant Change Guide, third revision
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2013 The IPEC Certificate of Analysis Guide
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2010 The IPEC Excipient Stability Program Guide
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2009 The IPEC Excipient Composition Guide
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2009 The IPEC Excipient Information Package (EIP): Template & User guide
Download PDF format
2009 The IPEC Quality Agreement Guide & Template
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2008 Qualification of Excipient for Pharmaceutical Use
Download PDF format
2008 The IPEC-PQG Good Manufacturing Practices Audit Guideline
Download PDF format
2006 The IPEC-PQG Good Manufacturing Practices Guideline
Download PDF format
2011 The IPEC Good Distribution Practices Audit Guideline
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2006 The IPEC Good Distribution Practices Guideline
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is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question

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