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Excipients - GMP/GDP Guidance documents

EFPIA

EFPIA Position Paper "GMP for Excipients"

Excipact

Certification Standards for Pharmaceutical Excipients Supplier: GMP and GDP - Requirements for Auditor Competency and 3rd Party Audit Organisations providing certification of the Management System

IPEC Guidelines

2014 The IPEC Significant Change Guide, third revision:
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2013 The IPEC Certificate of Analysis Guide
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2012 The IPEC Excipient Information Package (EIP): Template & User 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 Quality Agreement Guide & Template
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2008 Qualification of Excipient for Pharmaceutical Use
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2008 The IPEC-PQG Good Manufacturing Practices Audit Guideline
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2006 The IPEC-PQG Good Manufacturing Practices Guideline
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2011 The IPEC Good Distribution Practices Audit Guideline
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2006 The IPEC Good Distribution Practices Guideline
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