Definition: A three-stage validation protocol for cold chain equipment ensuring it is properly installed, operates correctly, and performs consistently under actual use conditions.
Why It Matters: IQ/OQ/PQ is mandatory for pharmaceutical cold chain (GDP requirement). Provides documented evidence that equipment performs as required. Essential for regulatory compliance and audit readiness.
IQ (Installation Qualification):
– Verify equipment installed per specifications
– Check utilities (power, drainage)
– Confirm component installation
– Document serial numbers, calibration certificates
OQ (Operational Qualification):
– Test equipment functions correctly
– Verify alarm systems work
– Test temperature control at setpoints
– Check defrost cycles
PQ (Performance Qualification):
– Test under actual operating conditions
– Loaded capacity testing
– Door opening simulations
– Power failure recovery
Related Terms: Temperature Mapping, Validation, GDP, Calibration, Commissioning