Module 3 - Strategic case studies in practice

Schematic Flow Diagram for Identification of CMAs/CPPs

Can the CQA be impacted by formulation and process variables?

No or low potential

Is variable shown to be or likely to be practically significant?

Does studied range capture intended variability?

Yes*

Yes

No

No

Yes

* Changes to the range may impact criticality and need to be re-assessed!

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