qualification
- Guideline or reference source
- ICHQ7 Good manufacturing practice for active pharmaceutical ingredients
- Definition
- Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.
- Broader Term
- validation
- Narrower Term
- design qualification
- installation qualification
- operational qualification
- performance qualification
- Related Term
- qualification protocol
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