Module 3 2019

3.2.S.2.4 Control of Critical Steps and Intermediates - 2 ➢ Risk based approach to identifying CQAs and hence critical steps, for example: o Reaction conditions on impurity formation o Crystallisation conditions on solid state form ➢ Criticality Score = Impact x Uncertainty o Impact (safety/efficacy effects): Very High (20), High (16), Moderate (12), Low (4), Very Low (2) o Uncertainty (occurrence likelihood): Very High (7), High (5), Moderate (3), Low (2), Very Low (1) o Range 2 – 140; define threshold for CQA eg ≥100

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