WEBINAR
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.
For further information, please contact info@ipec-europe.org.
IPEC Europe develops and publishes guidelines to promote the best use of excipients in medicines as a means of improving patient safety.
Since 1992, IPEC Europe brings together producers, distributors and users of pharmaceutical excipients to exchange good practices and develop harmonised standards.
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.
Together with its sister associations (Americas, Japan, China, India), IPEC Europe is a member of IPEC Federation, who promotes quality in pharmaceutical excipients worldwide.