Guidelines
The ECA Foundation's various Interest and Working Groups contiuously work on developing guidance documents, Good Practice Guides and white papers, supporting the information exchange between all stakeholders in both industry and regulatory authorities. Find out more in the Guides & Documents section.
The Team
The ECA Foundation's modern structure allows to develop and include the activities of the various Interest and Working Groups and to have more flexibility to build new groups that support the needs of our ECA Academy’s members. All members of the three boards work on a voluntary basis. For more details please see our Team section.
News
On a regular basis the Interest and Working Groups report about their activities and their accomplishments. Thus, to learn more about what they have been working on and for other latest developments in the ECA Foundation, you may want to check the news section.
What's new?
ECA Groups inform about their activities between May and August 2025
To find out what the ECA Foundation Associations, Interest and Working Groups' were working on and accomplished between May and August 2025 please read their latest report.
50 Years of Qualified Person Regulation in Europe
This year marks the 50th anniversary of the Qualified Person (QP) in the European pharmaceutical framework – a milestone that highlights five decades of commitment to patient safety and product quality. To commemorate this important anniversary, the European QP Association (EQPA) has published an in-depth article reflecting on the history, evolution, and future of the QP role in Europe. You can find the article in the latest EQPA Newsletter.
ECA Foundation Task Force comments on new EU GMP Guide Annex 22 Draft
The ECA Foundation formed an Annex 22 Task Force to prepare and submit comments to the new Annex issued on 7 July 2025. Find out more about what comments the Task Force submitted.
ECA Microbiology Group publishes Q&As on Bioburden
The questions in this Q&As Document on Bioburden were compiled from the ECA Bioburden workshops held over the past three years. The answers were written in close cooperation with and to the best of the knowledge and belief of the experts who gave the presentations. This document is not an official guideline and is in no way binding. It reflects, with limitations, the current state of science and technology as well as the experience of the experts involved, and contains non-binding recommendations. To download the Bioburden Q&As, please visit the Members Area of the Microbiology Group Website. If you are not yet a member, simply apply for membership - membership is free of charge.
On the Road to 30,000 Members
The ECA Foundation has an ambitious goal: to increase the number of members in its ECA Academy and ten Associations, Interest and Working Groups from currently 20,000 professionals from almost 60 countries to 30,000. Learn more about this ambitious goal - and about the special promotion of PharmaCongress & PharmaTchnica Expo 2026.
European QP Association organises 20 Years Anniversary QP Forum
The 2025 Qualified Person Forum is a jubilee highlight: The Qualified Person (QP) was first introduced into EU legal texts in the year 1975. We therefore celebrate its 50th birthday! And it is the 20th QP Forum, and, as every year, intended to help QPs face current and prepare for future challenges. After an inspirational opening by Patricia Kelly, Artist, Entrepreneur and Member of the Kelly Family, a lot of hot topics for QPs will be discussed in the various presentations and interactive sessions. Please see the details on the QP Forum website.
New ECA Guidance on Sampling and Sample Management
The ECA Analytical Quality Control Group (AQCG) has published a new guidance document on Sampling and Sample Management. The PDF file is available for free in the AQCG website members area. And if you're not a member yet, simply register for a free membership.