validation protocol
- Guideline or reference source
- ICHQ7 Good manufacturing practice for active pharmaceutical ingredients
- Definition
- A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling, test data to be collected, number of validation runs, and acceptable test results.
- Related Term
- test plan
- validation
- validation master plan
- validation process
- validation report
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