Updated: IPEC Quality Agreement Guide and Template(s)

Category: IPEC Federation
  • 21 Feb 2024

The International Pharmaceutical Excipients Council Federation, (IPEC Federation) announces the availability of the updated IPEC Quality Agreement Guide and Template(s) for Pharmaceutical Excipients (Version 3, 2024). The guide was first published as an IPEC Federation Guide in 2017. This guide is widely used globally.

The purpose of the Quality Agreement is to define which party is responsible for delineated quality activities and how quality issues will be resolved. The agreements are intended to formalize quality commitments between the parties to ensure there are appropriate quality procedures in place.

The content in the 2024 revision has not changed significantly but the review process ensures that it reflects current best practices, as well as confirming alignment with IPEC’s general guideline policies and format requirements.

Throughout the guide, efforts were made to remove redundancies and to update references to include more current regulations and guides/guidelines.

The guide will be available, initially exclusively to IPEC members for a three-month period, on the IPEC Federation and national/regional members’ websites. Thereafter, the guide will be made available to the general public.

IPEC Europe Members can access the Guide now by accessing the Member's Lab: CLICK HERE