Importance of the PQ – Performance Qualification
A documented verification that installations, plants and equipment operate effectively and reproducibly in the form that they were interconnected, on the basis of the approved process method and product specification. (EU GMP Guidelines, Annex 15)
The PQ is carried out after completion of the OQ. Implementation of a PQ takes place prior to the process validation or the cleaning validation.
As a rule, the PQ only applies to complex networked systems, for example a pharmaceutical production plant, a filling machine, ultrapure water plants, etc.
The basis for the tests is the approved product specification, the requirement specifications, on which, for example, a placebo test is carried out. The criteria are performance parameters – value ranges – upper and lower limits, such as:
- Temperature limits
- Rotational speed ranges
- Pressure ranges
- Flow rates
- Agreed performance parameters / Efficiency outputs
- Number / pieces
- Accuracies / Tolerances
- etc.
SEEFRIED Verfahrenstechnik GmbH supports you in compiling the documentation and verification of the PQ – Performance Qualification.
To complete the qualification work, it is usual to compile a comprehensive report on all the steps of the qualification work. As a rule this includes, starting with the risk analysis, the DQ - Design Qualification, IQ - Installation Qualification, OQ - Operational Qualification and PQ - Performance Qualification, as well as the aforementioned final report. We will be pleased to assist you with all the steps mentioned.
Would you like to complete the qualification of your plant reliably? Call us at +49 4203 789492, email info@s-vt.net or use our contact form.
Frequently Asked Questions about performance qualification (PQ)
What is performance qualification (PQ)?
PQ is the documented verification that interconnected facilities, systems and equipment operate effectively and reproducibly based on the approved process method and product specification (EU GMP Guidelines, Annex 15).
When is the PQ carried out?
After successful completion of the OQ and always before process or cleaning validation.
Which plants require a PQ?
Usually complex, networked systems such as pharmaceutical production plants, filling machines or purified water plants.
Which criteria are tested in the PQ?
Performance parameters with upper and lower limits, e.g. temperature, speed, pressure, flow, agreed output as well as accuracies and tolerances – often within a placebo test.
What completes the qualification?
A comprehensive report covering all steps – from the risk analysis through DQ, IQ and OQ to PQ.