Support worst-case product selection
Worst-case selection needs a scientific rationale and assessment of new products.
CV-REQ-000004
FDA · CV-REQ-000014
Reflect actual equipment use
REGULATORY SOURCE · PARAPHRASED SUMMARY
What the source says
Cleaning validation should reflect how equipment is actually used.
Read the original passage ↗CLEAN VALIDATED INTERPRETATION · DRAFT
Connect it to your work
Compare the study sequence with the production schedule it is intended to support.
AUDIT FOCUS · SUGGESTED QUESTION
Which production sequences are represented?
RECOMMENDED PRACTICE · ILLUSTRATIVE EVIDENCE
A starting point for your review
- Equipment-use matrix
- study sequence
These examples are editorial suggestions, not additional regulatory requirements. Applicability depends on your operation and the complete source.