Demonstrate sampling recovery
Recovery should be demonstrated for sampled contact materials and methods.
CV-REQ-000001
AUTHORITY / European Union
EU GMP
European Commission
Source documents
Connected references
Justify residue acceptance limits
Carryover limits require toxicological justification and consideration of equipment trains.
CV-REQ-000002
Define dirty and clean hold times
Account for both pre-cleaning and post-cleaning storage intervals.
CV-REQ-000003
Support worst-case product selection
Worst-case selection needs a scientific rationale and assessment of new products.
CV-REQ-000004
Use visual inspection within validation
Visual inspection alone is generally insufficient for cleaning validation.
CV-REQ-000005
Justify sampling locations
Protocols should identify sampling locations, their rationale and acceptance criteria.
CV-REQ-000006
Include microbial and endotoxin risk
Consider microbial and endotoxin contamination when developing protocols.
CV-REQ-000007