Development & Verification

Contestability & redress

Data & digital tools: 

The principle of Contestability & Redress may not currently apply during Development & Verification 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.

Personnel Training:

Currently, training related to Contestability & Redress may not be necessary during Development & Verification 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 Q8(R2): https://database.ich.org/sites/default/files/Q8%28R2%29%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

ICH Q13: https://database.ich.org/sites/default/files/ICH_Q13_Step4_Guideline_2022_1116.pdf

ISO/IEC 23894:2023 (Information technology — Artificial intelligence — Guidance on risk management): https://www.iso.org/standard/77304.html

ISO/IEC 27001:2022/Amd 1:2024 (Information security, cybersecurity and privacy protection — Information security management systems — Requirements): https://www.iso.org/standard/88435.html

ISO/IEC 27002:2022 (Information security, cybersecurity and privacy protection — Information security controls): https://www.iso.org/standard/75652.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

ASME VV40: https://www.asme.org/codes-standards/find-codes-standards/assessing-credibility-of-computational-modeling-through-verification-and-validation-application-to-medical-devices

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

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 Reflection Paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf

EMA Artificial Intelligence: https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/artificial-intelligence

EMA Artificial intelligence workplan to guide use of AI in medicines regulation: https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation

EU AI Act Article 9: Risk Management System: https://artificialintelligenceact.eu/article/9

EU AI Act Article 12: Record-Keeping: https://www.euaiact.com/article/12

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