Concept & Risk Analysis
Contestability & redress
Data & digital tools:
Legal responsibilities for the use of the digital CMC tool(s) reside with the holder or sponsor of the Marketing Authorisation or Clinical Trial Authorisation, as defined in the legislation of the relevant jurisdiction.
Personnel Training:
Currently, training related to Contestability & Redress may not be necessary during Concept & Risk Analysis for digital predictive tools in chemistry manufacturing and controls. However, as AI and other technologies are developing at rapid rate, this may change in future. Please consult the references for this section for more information.
Links
ICH Q7: https://database.ich.org/sites/default/files/Q7%20Guideline.pdf
ICH Q9(R1): https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2025_0115_0.pdf
ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdf
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
FDA Good Machine Learning Practice for Medical Device Development: Guiding Principles: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles
FDA Guidance for Industry Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-dispute-resolution-scientific-and-technical-issues-related-pharmaceutical-cgmp
FDA Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contract-manufacturing-arrangements-drugs-quality-agreements-guidance-industry
FDA Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations
FDA Data Integrity and Compliance With Drug CGMP: Questions and Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers
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
EMA Quality defects and recalls: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/quality-defects-recalls
Artificial Intelligence Playbook for the UK Government: https://www.gov.uk/government/publications/ai-playbook-for-the-uk-government/artificial-intelligence-playbook-for-the-uk-government-html
UK Government A pro-innovation approach to AI regulation: https://www.gov.uk/government/publications/ai-regulation-a-pro-innovation-approach/white-paper