Resources
Articles and guides on AI in pharmaceutical GMP manufacturing.
AI in GMP Manufacturing: A Practical Guide for Quality Professionals
Where AI actually adds value in GMP QA workflows, what Annex 11/22 and FDA Part 11 require, and the two-lane architecture that makes compliance practical.
By Toon Lambrechts | Published May 20, 2026
How to Evaluate LLMs for Pharmaceutical Compliance Tasks
A practical framework for assessing large language models on pharmaceutical compliance work, from regulatory knowledge to document generation.
By Toon Lambrechts | Published May 22, 2026
AI Agents in GMP Quality Assurance: Use Cases and Considerations
How agentic AI can support deviation investigations, batch release, CPV, and CAPA in pharmaceutical QA, with the compliance guardrails bounded autonomy requires.
By Toon Lambrechts | Published May 24, 2026
Why General AI Benchmarks Fail for Regulated Industries
Why generic LLM benchmarks fall short when evaluating AI for pharmaceutical, medical device, and other regulated industry applications.
By Toon Lambrechts | Published May 26, 2026
FDA and EMA Perspectives on AI in Pharmaceutical Manufacturing
Where FDA cGMP, Part 11, and PAT guidance meet draft EU GMP Annex 22 and the EU AI Act, and what converges across both regulators for AI governance.
By Toon Lambrechts | Published May 29, 2026
Summary of the Fine Print on AI Data Use
How major AI providers handle your data on consumer and enterprise tiers, and what it means for regulated environments.
By Toon Lambrechts | Published June 1, 2026