Performance Qualification confirms that the equipment and systems meet the users’ needs and is fit for intended use as defined in the user requirements specification (URS). It is the final step in equipment qualification.
It is much like Operational Qualification, as it tests the operational requirements of the equipment, but in this case, the equipment will contain a load or process medium.
In other words, you test the equipment while it’s being subject to “real-world” conditions – conditions which the equipment would be subject to during batch production.
This phase is hugely important as it combines the workings, forces and energy of the individual components of the equipment into one harmonious system. By doing so, faults such as the examples below (as well as many more) can be discovered in this phase of qualification:
- Excessive Vibration/Noise – This may be caused by a combination of 2 or more individual vibrating components leading to resonance.
- Excessive Heat – This may be caused by a build-up of heat due to a driving belt.
- Process Media Backflow – This may be caused by incorrect sizing of pipework (a factor that is only highlighted in this case).
- Pressure Differentials – This may be caused by the use of a valve (toggle open/closed) or other equipment, as well as process media backflow, as mentioned above.
- Combination of Individual Faults – Problems in the system can also arise due to a combination of these faults.
Check out 4 professional IQ, OQ PQ Templates you can use right now to help with your qualification and validation projects.
Performance Qualification must not be confused with Process Validation (PV) (or qualification that is the verification that good product is made) or with validated cleaning and analytical methods.