Context: IQ/OQ/PQ are qualification stages in validated environments. IQ demonstrates correct delivery, installation and documentation. OQ demonstrates operation in line with specifications under defined conditions. PQ demonstrates reliable performance in intended use.
Why it matters: The evidence makes requirements, tests, calibration, deviations and approvals traceable and supports process validation under real-world conditions.
The three stages:
- IQ – Installation Qualification: Evidence of delivery, installation, configuration and documentation in line with specifications.
- OQ – Operational Qualification: Evidence of operation in line with specifications under defined conditions, including limit and worst-case conditions.
- PQ – Performance Qualification: Evidence of reproducible performance under routine conditions with real materials, personnel, environment, sampling and process monitoring.
Distinction: IQ/OQ/PQ do not replace a validation strategy. In process validation, the number of batches and the sampling depth are determined on a risk basis.
Short version: IQ/OQ/PQ demonstrate installation, operation and performance for the intended GxP use.
Further reading: