Recording from Wednesday, June 24, 2020
This webinar will reviewed the recently re-issued IPEC Excipient Information Package User Guide and Templates. This guide is designed to facilitate the excipient supplier's sharing of information with the user in a standardized way. The guide and templates were first published in 2005 then subsequently revised in 2009, 2013 and 2020. An overview of the guide/template and major revisions will be provided.
In addition, presenters will review IPEC-Americas thoughts and position on "Data Integrity for Pharmaceutical Grade Excipients" as well as "Selecting Appropriate Excipient GMPs".
The revised Excipient Composition Guide will also be discussed. The guide was originally published in 2009 and is now being revised to update the references contained therein and has been converted into an IPEC Federation guide, representing inputs from all IPEC members, namely the Americas, China, Europe, India and Japan.
Learning Objective
> Overview of the IPEC EIP User Guide and Templates, including recent major changes
> IPEC’s position on the relevance of data integrity guidance documents to the manufacture and supply of excipients
> Understanding for data integrity concepts explicitly included in excipient GMP standards and guides
> Excipient data integrity recommendations for excipient manufactures and users
> Explanation for multiple excipient GMP documents available and how they may be used
> Ability to make an informed decision regarding which excipient GMP document to adopt