Performance Qualification (PQ) is the part of Qualification of an Equipment or an Instrument. Let us check it out what is performance Qualification? It is the documented collection of activities which are necessary to demonstrate that an instrument consistently performs according to the specifications defined by the user and is appropriate for the intended use.
- Tests to include a condition or a set of conditions encompassing upper and lower operating limit.
- Tests, using production materials, qualified substitutes or stimulated product, that have been developed from knowledge of the process and the facilities, systems or equipment.
- Tests to include a condition or set of conditions encompassing upper and lower operation limits.
- Tests that verify the efficacy of sterilization cycles (cleaning validation).
- Verify that procedures describing calibration, maintenance, operation, and training are implemented.
- In the previous phases, it was not required that these procedure were approved, effective, and implemented , but in this phase routine operation is simulated and the procedures should be implemented.