Home How to use EXCiPACT GMP Certification of excipients
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How to use EXCiPACT GMP Certification of excipients

by cyb2025
I. Moore
ascertaining GMP
audit burden
Certification
EXCiPACT
excipient
outsourcing
supplier approval

Dr Iain Moore retired at the end of 2023 as the Head of Global Quality Assurance at Croda International, a supplier of many types of high purity excipients, APIs and vaccine adjuvants. He has contributed to the publication of both European and US National Standards and the development and operation of the EFfCI GMP Certification Scheme for cosmetic ingredients. He is an active member of IPEC Europe. Since 2007 he has been instrumental in the team that took the IPEC-PQG GMP Guide 2006 and converted it to the EXCiPACT Certification Scheme for Pharmaceutical Excipients. He has served as President for two terms and is currently a Senior Advisor Operations to the EXCiPACT association.

ABSTRACT

Ever since the publication of the 2006 IPEC-PQG GMP Guide for pharmaceutical excipients, suppliers have needed to demonstrate they have applied those GMPs. Thus, was born, EXCiPACT, the GMP/GDP excipient certification scheme which shares not only the certificates but also the audit reports. The way EXCiPACT can be implemented by excipient suppliers and used by drug product manufacturers is explained, with the benefits both parties can obtain. Recent publication by the regulatory authorities has clarified how EXCiPACT and other 3rd party audit schemes can be used is also highlighted.

EXCiPACT GMP Certification of pharmaceutical excipients has been providing trustworthy demonstration of the supplier’s commitment to the industry for over 10 years. With over 220 certificates issued to suppliers worldwide there has been growing international acceptance of the value and contribution EXCiPACT Certification makes to securing the excipient supply chain. Proactive feedback from users, compendia and regulators makes EXCiPACT GMP Certification a valuable way to reduce audit burdens. The flexibility in applying a suitable GMP which is a cornerstone of the EXCiPACT standards can also be applied to non-excipient materials that need to be manufactured to GMP principles. EXCiPACT also includes Good Distribution Practice (GDP) and a Good Warehouse Practice (GWP) for unopened packs. Collectively these are known as GxP.

 

What is EXCiPACT Certification?

 

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