Question 6 of 6 Advanced Scenario
How would you assess quality risks before approving a planned change?
Short answer
Define the proposed change, affected quality attributes and regulatory commitments, estimate credible failures and select proportionate controls and verification before approval.
Why
A new supplier for a critical reagent might alter impurity profiles, assay performance or product stability even when the supplier certificate is acceptable. Assemble cross-functional process, quality, regulatory and analytical knowledge to map what can change and how that change could affect patient-relevant attributes. Prioritize risks using severity, likelihood and detectability where useful, but do not treat the numerical score as objective truth.
Specify comparability or qualification data, acceptance criteria, documentation updates and an effectiveness review. Ensure regional reporting obligations are addressed before implementation, and separate an approved plan from evidence that execution succeeded. Formality should reflect complexity and uncertainty.
Residual risk must remain visible with a clear owner rather than disappear after an approval signature.
Common mistakes
- Using a low risk score to bypass a requirement that still applies under CGMP
The interviewer might ask next
How would the plan change if the reagent is used in the final sterile filling step?