Date: July 7, 2025
On July 7, 2025, the European Commission’s Directorate-General for Health and Food Safety opened a stakeholders’ consultation on three drafts for EudraLex Volume 4, the EU GMP guide: a revised Chapter 4 on documentation, a revised Annex 11 on computerized systems and a new Annex 22 on artificial intelligence. EMA’s GMDP IWG prepared the drafts in cooperation with PIC/S, and the consultation closed on October 7, 2025. As of October 26, 2026, EudraLex Volume 4 still lists the January 2011 Chapter 4 and Annex 11 and has no Annex 22. The GMDP IWG work plan for 2026 to 2028 targets the fourth quarter of 2026 for delivering final texts of all three to the European Commission; no publication date has been announced.
The draft Annex 11 has 17 sections, among them alarms, identity and access management, audit trails, electronic signatures, periodic review, security, backup and archiving. It applies to “all types of computerised systems used in the manufacturing of medicinal products and active substances” (Section 1).
Draft Annex 22 covers static machine learning models with deterministic output used in critical GMP applications. Dynamic models, probabilistic models, generative AI and large language models “should not be used in critical GMP applications” (Section 1), and a model’s acceptance criteria “should be at least as high as the performance of the process it replaces” (4.3).
Draft Chapter 4 calls for a data governance system integral to the pharmaceutical quality system (4.10) that covers the entire data lifecycle (4.12), and asks regulated users to define which data are raw data for electronic records (4.27).
What it means for calibration
Draft Annex 11 names calibration and laboratory data directly. Before testing a system, it should be verified, where applicable, that “relevant components have been properly calibrated” (9.3). Critical data moving “from a laboratory instrument to a LIMS system” should, where possible, pass through validated interfaces rather than manual transcription (10.2), so a calibration result retyped from a CDS into a LIMS or a spreadsheet would need measures showing that the transcription adds no data integrity risk.
The audit trail clauses reach routine calibration work. Section 12.2 asks the audit trail to record who changed what, with the old and new values, and when, and to prompt for the reason; Section 12.3 says audit trail functionality “should be enabled and locked at all times.” In a CDS, excluding a calibration standard, changing a weighting factor or reintegrating a peak are manual user interactions the draft expects to be logged, with a prompted reason where a value changes, and Section 12.8 places audit trail review before batch release unless later detection is justified. Draft Chapter 4 also lists calibration among the equipment factors behind accurate data (4.63, Table 1).
Also see: health.ec.europa.eu, Draft Annex 11: Computerised Systems (consultation version, 2025); health.ec.europa.eu, Draft Annex 22: Artificial Intelligence (consultation version, 2025); health.ec.europa.eu, Draft Chapter 4: Documentation (consultation version, 2025); health.ec.europa.eu, EudraLex Volume 4, Good Manufacturing Practice guidelines; ema.europa.eu, GMDP IWG 3-year work plan, January 2026 to December 2028
Part of the WLTR ICH M10 guide for pharmaceutical and bioanalytical labs. This is a plain-language summary, not regulatory advice. Confirm requirements with the issuing agency and your quality unit. Questions or a different read on this change? Leave a comment below.