Provider (Art. 16)
AI software vendor for pharma: GAMP 5 dossier + EMA AI alignment + Annex IV when the case triggers it.
AI Assurance — Pharma
GAMP 5 remains the backbone. AI demands something more.
GAMP 5 validates deterministic software; AI is probabilistic and every retraining is a GxP change. The EU AI Act applies selectively — only to cases like clinical decision support, critical production control or essential services — not as a horizontal layer across the entire portfolio.
What we see in this sector
Every retraining triggers full GxP re-validation — paralyses innovation.
EMA Reflection Paper (2024) introduces expectations that do not fit traditional GAMP 5 templates.
ALCOA+ does not detect algorithmic bias — explicit gap versus classical data integrity.
Typical use cases
- Predictive QC in manufacturing line (PAT, critical control → EU AI Act applies)
- Batch and continuous process optimisation
- Automated pharmacovigilance (essential public services → EU AI Act applies)
- Clinical decision support for dosing (high-risk → EU AI Act applies)
Applicable regulatory frameworks
Primary frameworks
ISPE GAMP 5 — Validación GxP de software
GAMP 5 · Official source →
Pharmaceutical software validation — each retraining is a GxP change.
EMA Reflection Paper on AI in the Medicinal Lifecycle (2024)
EMA/CHMP 2024 · Official source →
EMA-specific framework for AI in medicines.
Cross-cutting frameworks
Reglamento (UE) 2024/1689 — Reglamento de Inteligencia Artificial
Reg. (UE) 2024/1689 · Official source →
EU AI Act. Applies whenever the system operates in the EU.
ISO/IEC 42001:2023 — Sistema de Gestión de IA
ISO/IEC 42001:2023 · Official source →
Voluntary AI management framework, alignable with the EU AI Act.
GDPR Art. 22 — Decisiones automatizadas
Reg. (UE) 2016/679 Art. 22 · Official source →
Automated individual decisions with legal effects on people.
AI supply chain — your role determines your obligations
The EU AI Act distributes obligations by role (Arts. 16, 24, 26). In this sector each role contributes a different piece to assurance.
Integrator (Art. 24)
On-site integrator: cross-validation GxP + selective AI Act — case-by-case, not horizontal.
Deployer (Art. 26)
Pharma company: model lifecycle with QbD/QbR applied and automatic change traceability for regulators (EMA, AEMPS, FDA where applicable).