|Валидация однородности смеси|
|Performance qualification (PQ)|
Performance qualification (PQ) is the process of demonstrating that an instrument or equipment consistently performs according to the specification appropriate for its routine use.
PQ can mean system suitability testing, where critical key system performance characteristics are measured and compared with documented, preset limits. For example, a well characterized standard can be injected five or six times and the standard deviation of amounts are then compared with a predefined value.
Performance qualification includes:
- Definition of performance criteria and test procedures.
- Selection of critical parameters with some allowance to drift out of predefined specifications.
- Determination of the test intervals, e.g.,
- Every time the system is used.
- Before, between and after a series of runs.
- Define corrective actions on what to do if the system does not meet the established criteria.