EMA held an AI-in-GMP workshop on June 30-July 1, 2026. The first day was an open expert session. The second day supported the closed Annex 22 drafting group. The guidance will address AI used in medicines manufacturing. EMA planning documents indicate publication is expected in early 2027.
How Do AI, digital health, and computer system validation Change Work?
Manufacturers increasingly use AI without one dedicated EU GMP annex defining lifecycle and oversight expectations. EMA gathered expert evidence during a two-day workshop to support drafting of Annex 22. The workshop ran for two days, June 30 and July 1, 2026, with publication expected in early 2027.
Impact Across AI, digital health, and computer system validation
Positive effect: Dedicated guidance may improve consistency in risk assessment, validation, monitoring, and human accountability. Risk: Overly rigid implementation could slow beneficial tools, while weak controls could threaten data and product quality. Implementation challenge: Companies must validate changing models, manage suppliers, control data, and define accountable human review.
Career Skills for AI, digital health, and computer system validation
The update matters because it changes how organisations plan, document, communicate, or control regulated work. Professionals do not need to predict every outcome. They should understand the verified change, identify role impacts, and build evidence around the most relevant skills.
For QA: Practical Career Impact
QA teams may own policy, risk classification, change control, and ongoing monitoring. Candidates should connect this impact with evidence from projects, training, placements, or regulated workplace responsibilities.
- Daily-work impact: QA teams may own policy, risk classification, change control, and ongoing monitoring.
- Learn or review: AI governance, data integrity, supplier quality, and human oversight.
Next Results After 2 days
Teams should inventory AI use and strengthen governance before the draft becomes a formal compliance reference. Professionals should monitor the official source, assess documented gaps, and prepare role-specific examples before interviews, audits, submissions, or implementation work.
Build context with Computer System Validation in Pharma Guide and strengthen practical knowledge through Introduction to Computer Systems Validation.