Webinar - The IPEC Significant Change Guide

An IPEC Europe webinar

The IPEC Significant Change Guide


21 November 2023 – 15:00-15:45 CET

The IPEC Significant Change Guide for Pharmaceutical Excipients provides a consistent approach to evaluate the significance of changes with regard to the manufacture and the distribution of excipients.

The 2023 revision of the guide has retained much of the original content but has been updated to better align with the general guideline policies and format requirements of IPEC. These updates include harmonized terminology and general statements, the relocation of content to more relevant sections, and the incorporation of decision trees into the main body of the guide.

This webinar aims to provide a practical approach to the Significant Change guide. Different scenarios and practical examples will be presented and discussed to deepen the understanding of GMP-compliant requirements for excipient manufacturing and distribution. This involves considering both the requirements of the users and the constraints of the manufacturers.

The webinar is free of charge for IPEC Europe Members.

Registration for this webinar is now closed. Please contact info@ipec-europe.org for further information.

For further information, please contact info@ipec-europe.org.


Member of EXCiPACT

EXCiPACT is a non-profit organisation that owns and manages oversight of the independent, high quality, third-party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.

IPEC Federation

Member of IPEC Federation

Together with its sister associations (Americas, Japan, China, India), IPEC Europe is a member of IPEC Federation, who promotes quality in pharmaceutical excipients worldwide.