AI is increasingly part of how information is produced, reviewed and used to support decisions. In pharmaceutical quality and manufacturing, this raises technical, regulatory and ethical questions that deserve to be explored together.
EPAI is a sketchpad of thoughts on AI and ethics in pharma, trying to spark some reflection. You do not need a technical background in AI to begin.
A suggested place to begin
1. Understand the technology
Start with the distinctions between AI, machine learning, deep learning and generative AI.
- Understanding AI, Machine Learning, Deep Learning and Generative AI
- Static, Adaptive, Probabilistic or Deterministic AI
2. Think about GMP and validation
Explore what it means to control, validate and explain AI-assisted activities in pharmaceutical quality systems.
- Can We Really Keep AI in a Validated State?
- AI in GMP: Are We Ready to Explain What We Are Doing?
- Can AI Validate Itself?
3. Consider responsibility and ethics
Move beyond technical capability to ask how judgement, risk and accountability should be approached.
Other ways to explore
Browse the AI Fundamentals, AI in GMP, Ethics & Responsibility and Regulation & Governance collections, or use the Reading Map to follow connections between the articles.
These are personal reflections informed by professional experience, not regulatory guidance. Where draft documents are discussed, they should not be mistaken for binding requirements.
