QGP Short: AI in GMP Environments - Risks and Regulatory Guidance
Update: 2025-07-29
Description
In pharmaceutical and biotech manufacturing, artificial intelligence is no longer a future concept. It’s here, supporting product development, process control, and quality decisions in GMP-regulated environments. But with this opportunity comes significant responsibility. While AI offers powerful capabilities, it also introduces a new set of risks, ones that must be managed to meet compliance, safety, and quality expectations.
In this Quality Grind Short - Mike outlines both the risks and opportunities that AI provides, and highlights guidance being provided by global regulatory agencies.
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