Conference Report on the GMP Forum 2025 in Barcelona
This year's European GMP & GDP Forum took place in Barcelona from June 24 to 26, 2025. The first day and a half focused on GMP topics, while the following day and a half was devoted to current developments in the field of Good Distribution Practice (GDP). Participants had the option of attending either the GMP Forum, the GDP Forum, or all three days of the event.
The GMP Forum, which began on June 24, 2025, aimed to highlight current GMP developments in the EU and the US. The first day was moderated by David Cockburn, member of the European Compliance Academy (ECA) Executive Board. At the beginning, Dr Afshin Hosseiny, Head of the ECA Executive Board, gave an overview of the development of the ECA as a whole and of the developments in the individual ECA interest and working groups. His conclusion: the ECA is a key stakeholder in the GMP environment.
Brendan Cuddy, Lead Scientific Officer at the EMA, then provided the first highlight with his presentation "Update on Inspections, MRAs, and Working Plan". Among other things, he reported on the Quality Innovation Group (QIG), which is currently working on two guidelines on decentralized manufacturing and 3D printing. Even more exciting was Brendan Cuddy's outlook on changes to GMP rules. There is a lot happening... (see Figure 1 "Modernization of GMP Guidelines" on p. 19)
Following Brendan Cuddy's presentation, Dr Ulrich Kissel, member of the ECA Executive Board and head of the European QP Group (EQPA), gave a presentation from the industry perspective: "Update on European GMP Regulations - Outlook". He used a slide to show how complex the regulation of drug manufacturing in Europe is nowadays and what is in store for the future, see Figure 2 on p. 19.
He also pointed out developments in the field of veterinary medicines and the many question-and-answer documents published by the EMA on Annex 1, Annex 8, Annex 16, and GDP.
Another highlight was the double presentation by Ib Alstrup, a Danish inspector who is leading the Annex 11 revision and the redrafting of Annex 22 on artificial intelligence. His discussion partner was Dr Wolfgang Schumacher, head of the ECA IT group. Ib emphasized that the draft document for both annexes has been agreed upon with the group of inspectors involved and is now with the EU Commission. The Commission is currently reviewing the document from a legal perspective. Publication is scheduled for September 2025. At the beginning of his presentation, he showed that there are IT security re-quirements in all GxP areas (GLP, GCP, GMP, GVP). He then gave an overview of the contents of the draft document Annex 11 Revision and Annex 22 Draft, see Figures 3 and 4 on p. 20.
Recommendation
10/11 February 2026
Handling of Foreign Particles in APIs and Excipients - Live Online Training
Figure 1: Modernization of GMP Guidelines
Figure 2: Overview of upcoming EU regulations for human medicines
Figure 3: Annex 11 Draft
Figure 4: Annex 22 Draft
In his customarily critical manner, Dr Wolfgang Schumacher then responded on the basis of the concept paper on the Annex 11 revision and the overview that is currently known about Annex 22. His presentation was titled "Pain Points and Industry Expectations." He began his presentation with a statement about general expectations of new regulations: "Validation should become easier and faster." "There should be a recipe for validation." He then used comparisons between the current Annex 11 and the contents of the concept paper to show that this will not be the case. And the use of artificial intelligence? Here, Wolfgang Schumacher saw "King Kong fighting Cyber Godzilla" (Figure 5 on p. 20). His industry perspective in particular was shared by the audience on several occasions.
Recommendation
Heidelberg, Germany10/11 February 2026
Combination Products
Figure 5: The future of artificial intelligence.
After the lunch break, Dr Peer Schmidt from Abbvie gave a presentation entitled "ICH Q9 Training Package - An Overview," providing an overview of the new ICH Q9 training material. As a member of the group that revised the ICH Q9 guideline, he was the ideal speaker to explain the new aspects of the revision and their inclusion in the training package. He began by showing that the original ICH Q8, Q9, and Q10 training material had been updated with 10 sets of slides, as had the question and answer document on these guidelines. The training materials for Annex 1 of the ICH Q9 (R1) guideline "Tools and Methods" and Annex 2 "Applications," each with 9 sets of slides, are still pending. All slide sets are expected to be published in September, see Figure 6 on p. 20.
Figure 6: ICH Q9 Briefing Package Revision
He then discussed the most significant changes compared to the previous version of ICH Q9 and used the new training slides to illustrate how to deal with:
- Hazard identification instead of risk identification
- Dealing with subjectivity
- Dealing with formalities
- Dealing with risk-based decisions
- Dealing with drug supply
- Dealing with risk review
Dr Ulrich Kissel then addressed another very special topic: "Global Functions in Pharma Large Organizations and EU GMP a critical discussion". He did an excellent job of highlighting the difficulties with regard to audits between global quality assurance structures, local qualified persons (QPs), and contractors. One participant spontaneously commented that she was experiencing the same problems.
At the end of the first day, Dr Hosseiny summarized: We all have the same goal-patient safety. A bus tour of the most important sights and dinner in Barcelona's old town provided opportunities for further exchange of ideas.
Dr Jörg Stüben from Boehringer Ingelheim opened the second day. He spoke about "Artificial Intelligence and Digitalization in Pharma." Dr Stüben engaged the participants at the beginning with Slido polls. He then presented different types of artificial intelligence and various guidelines (specific vs. non-specific). He expressed his regret that the upcoming Annex 22 on artificial intelligence excludes "large language models" and "generative AI." Ib Alstrup, head of the group drafting Annex 22, responded that this would be a first draft and could be further developed. Again using Slido polls, he then asked the audience to vote on the use of artificial intelligence in various cases in research, drug safety, IPC, and batch release. Finally, he gave the audience some "food for thought" (see Figure 7 on p. 21).
Figure 7: “Food for thought” on the use of artificial intelligence
The morning ended with two double presentations. First, Ralf Gengenbach, head of the ECA Validation Group, and Dr Franz Schönfeld, GMP inspector in Bavaria, spoke about the ECA Good Practice Guide "Qualification and Validation 3.0." Ralf Gengenbach began by giving an overview of the guide and what has changed in the current version 3.0 compared to version 2.2. The aim of the guide is to describe the cooperation between suppliers and customers in equipment qualification. As early as 2005, an ISPE white paper had promoted the integration of Good Engineering Practice (GEP) and cooperation between suppliers and customers (see Figure 8). That was 20 years ago.
Figure 8: Excerpt from the ISPE white paper on equipment qualification
Using the example of the Devonport scandal in 1972, Franz Schönfeld showed which GMP principles can be derived from the event (knowledge of equipment design, process and product knowledge, risk management). He explicitly recommended involving suppliers in equipment qualification. Suppliers often have better knowledge of the equipment than the customer, and tests carried out by suppliers do not necessarily have to be repeated by the customer. On the other hand, he also sees limits to supplier involvement. The following should be considered:
- Off-the-shelf vs. custom-designed equipment
- Experience and market position of the supplier
- The effective integration of GEP
- But, very importantly: The client remains responsible
And how are suppliers involved in qualification? Ralf Gengenbach offered some ideas on this topic. Starting with the product and process specifications, user requirements are placed on a piece of equipment. These are then incorporated into the planning, design, and construction of the equipment, accompanied by risk management activities. The supplier's expertise is incorporated into all activities.
In the last presentation before the lunch break, David Abraham, head of the working group that had created the ECA GMP Auditor Guide, presented the development of the guideline and gave a general overview of its content, "Introducing GMP Auditor Guideline".
Building on this, Dr Ingrid Walther, a member of the GMP Auditor Association, explored the content of the guideline in greater depth. Dr Walther focused in particular on the report form in the guideline, see Figure 9.
Figure 9: Excerpt from the report form (audit report)
Finally, she presented practical examples of difficult audit situations and possible solutions. This concluded the second day of the GMP Forum. After the lunch break, the GDP Forum continued.
Conclusion: With three exhibitors in attendance, the GMP Forum provided a platform for learning about developments in GMP regulations and current implementation options. Nearly 160 participants and speakers from 24 countries took full advantage of this opportunity.
The GMP & GDP Forum takes place every two years. The next forum is scheduled for June 2027.
About the Author
Sven Pommeranz is Operations Director and organises and conducts courses and conferences on behalf of the ECA Academy in the area validation.
