Support worst-case product selection
Worst-case selection needs a scientific rationale and assessment of new products.
CV-REQ-000004
EMA · CV-REQ-000023
Justify the changeover control strategy
REGULATORY SOURCE · PARAPHRASED SUMMARY
What the source says
Reduced analytical testing requires robust justification, including visual-inspection capability.
Read the original passage ↗CLEAN VALIDATED INTERPRETATION · DRAFT
Connect it to your work
Treat an exception as a documented decision with boundaries.
AUDIT FOCUS · SUGGESTED QUESTION
When must the exception be reassessed?
RECOMMENDED PRACTICE · ILLUSTRATIVE EVIDENCE
A starting point for your review
- QRM record
- inspection capability study
These examples are editorial suggestions, not additional regulatory requirements. Applicability depends on your operation and the complete source.