Conference Report: GMP Forum 2025 in Barcelona
This year’s European GMP & GDP Forum took place from 24–26 June 2025 in Barcelona. The first one and a half days focused on GMP-related topics, while the following one and a half days were dedicated to recent developments in Good Distribution Practice (GDP). Participants had the option to attend either the GMP Forum, the GDP Forum, or all three days of the event.
The GMP Forum, which commenced on 24 June 2025, aimed to provide an overview of current GMP developments in the EU and the USA. The first day was chaired by David Cockburn, member of the European Compliance Academy (ECA) Executive Board. To open the Forum, Dr Afshin Hosseiny, Chair of the ECA Executive Board, provided an update on the overall development of the ECA as well as on the progress of its various Interest and Working Groups. His conclusion: with more than 4,000 members, the ECA is a key stakeholder in the GMP environment.
The first highlight followed shortly thereafter: Brendan Cuddy, Lead Scientific Officer at the EMA, delivered his presentation “Update on Inspections, MRAs and Work Plan”. Among other topics, he reported on the Quality Innovation Group (QIG), which is currently working on two guidelines addressing decentralised manufacturing and 3D printing. Even more noteworthy was his preview of the forthcoming revisions to GMP regulations. There are significant changes underway….
Building on Brendan Cuddy’s presentation, Dr Ulrich Kissel, member of the ECA Executive Board and Chair of the European QP Association (EQPA), presented an industry perspective titled “Update on European GMP Regulations – Outlook”. He illustrated the complexity of today’s regulatory framework for medicinal product manufacturing in Europe and what is to come.
He also highlighted developments in the field of veterinary medicinal products and referred to numerous EMA Q&A documents related to Annexes 1, 8, and 16, as well as to GDP.
Another key session was the joint presentation by Danish inspector Ib Alstrup, who is leading the revision of Annex 11 and the drafting of the new Annex 22 on artificial intelligence. He was joined by Dr Wolfgang Schumacher, Chair of the ECA IT Group. Ib emphasised that the draft documents for both annexes have been reviewed in coordination with the involved inspector working groups and are now with the European Commission for legal review. Publication is expected in September 2025. He began his presentation by showing that all GxP areas (GLP, GCP, GMP, GVP) include provisions on IT security. He then gave an overview of the draft contents of the revised Annex 11 and new Annex 22.
As expected, Dr Wolfgang Schumacher responded critically, analysing the concept paper for the Annex 11 revision and the currently available information on Annex 22. His presentation, titled “Pain Points and Industry Expectations”, opened with a general industry sentiment regarding new regulations: “Validation should become easier and faster” and “There should be a recipe for validation”. He demonstrated, using comparisons between the current Annex 11 and the concept paper, that this is unlikely to be the case. Regarding the use of artificial intelligence, he envisioned “King Kong fighting Cyber Godzilla”. His industry perspective was widely echoed by the audience.