Define dirty and clean hold times
Account for both pre-cleaning and post-cleaning storage intervals.
CV-REQ-000003
FDA · CV-REQ-000013
Document the validation conclusion
REGULATORY SOURCE · PARAPHRASED SUMMARY
What the source says
A management-approved report should establish whether cleaning is validated.
Read the original passage ↗CLEAN VALIDATED INTERPRETATION · DRAFT
Connect it to your work
Make unresolved deviations visible alongside the overall conclusion.
AUDIT FOCUS · SUGGESTED QUESTION
Does the conclusion account for every deviation?
RECOMMENDED PRACTICE · ILLUSTRATIVE EVIDENCE
A starting point for your review
- Final report
- deviation disposition
These examples are editorial suggestions, not additional regulatory requirements. Applicability depends on your operation and the complete source.