Concept & Risk Analysis

Accountability & governance

Data & digital tools:

Development and implementation of digital CMC tools should be within appropriate pharmaceutical quality and management systems (GxPs) relevant to the phase of the lifecycle.

Personnel Training:

Ensure responsible digital innovation principles understood.

Links:

ICH Q7: https://database.ich.org/sites/default/files/Q7%20Guideline.pdf

ISO/IEC 5259:2024-2025 (AI data quality management bundle): https://www.iso.org/publication/PUB200525.html

ISO 42001:2023 (Information technology — Artificial intelligence — Management system): https://www.iso.org/standard/42001

ISPE GAMP Guide: Artificial Intelligence: https://ispe.org/publications/guidance-documents/gamp-guide-artificial-intelligence?utm_source=HubSpot&utm_medium=Popup&utm_campaign=Guide%20GAMP%20AI&hsCtaAttrib=192776150296

WHO Annex 4: Guideline on data integrity: https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/inspections/trs1033-annex4-guideline-on-data-integrity.pdf?sfvrsn=6218a4e6_4&download=true

EMA and FDA set common principles for AI in medicine development: https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0