Stage 8: Assess Risk of Control Strategy Models

In accordance with previous guidance from EMA, FDA and ICH (EMA, 2024; FDA, 2004; ICH Q1, Q8(R2), Q9(R1), Q10, Q14), further assessment should be carried out to evaluate how model uncertainty and limitations may propagate into manufacturing control decisions for models that inform or support control strategies. Clear communication of these uncertainties, assumptions, and limitations to regulators is essential, as it supports transparent regulatory assessment and informed oversight of decision-making impacts.