Updated: IPEC Qualification of Excipients Guide
Category: IPEC FederationIPEC Federation announces the publication of the updated IPEC Qualification of Excipients for Use in Pharmaceuticals Guide and Checklist (Version 3, 2026).
The guide, originally published in 2008, has been refreshed to ensure alignment with regulatory expectations. This guide is widely used globally.
Qualification of excipient suppliers is fundamental to secure the excipient supply chain and has never been more important in relation to recent tragic events related to adulterated substances used in making medicines.
The IPEC Qualification of Excipients for Use in Pharmaceuticals guide outlines best practices for establishing and maintaining effective relationships between excipient suppliers and users, with practical recommendations to address key challenges commonly encountered by both parties.
By promoting improved collaboration and communication, the guide supports the efficient use of excipients and helps streamline interactions with regulatory authorities.
The checklist aims to be a quick reference for topics to consider during the qualification of an excipient for use in medicinal products
The guide will be available, initially exclusively to IPEC members for a three-month period, on the IPEC Federation and national/regional members’ websites.
IPEC Europe members can access the full guide on the Member's Lab.