Reflect actual equipment use
Cleaning validation should reflect how equipment is actually used.
CV-REQ-000014
EU GMP · CV-REQ-000004
Support worst-case product selection
REGULATORY SOURCE · PARAPHRASED SUMMARY
What the source says
Worst-case selection needs a scientific rationale and assessment of new products.
Read the original passage ↗CLEAN VALIDATED INTERPRETATION · DRAFT
Connect it to your work
Record what the selected product represents and what it does not.
AUDIT FOCUS · SUGGESTED QUESTION
Which changes would invalidate the selection?
RECOMMENDED PRACTICE · ILLUSTRATIVE EVIDENCE
A starting point for your review
- Selection matrix
- change assessment
These examples are editorial suggestions, not additional regulatory requirements. Applicability depends on your operation and the complete source.