Global chemistry, manufacturing, and controls (CMC) postapproval changes (PACs) are still managed largely through fragmented, country-by-country processes that duplicate sponsor and regulator effort, increase cost, prolong implementation timelines, add supply chain complexity, discourage continual improvement, and delay patient-centric enhancements.

ICH Q12’s intent is to enable a holistic control strategy and provide regulatory tools for continual improvement over the product life cycle, thereby promoting innovation. However, slow implementation of ICH Q12 tools by regulatory agencies has created challenges for industry to fully use Q12 concepts in regulatory submissions.

The recent iSpeak blog post “Human-in-the-Loop as an Illusion of Control?” by Frank Henrichmann and Oliver Herrmann, raises an important question regarding the use of artificial intelligence in GxP environments.