Performance qualification (PQ) is the documented verification that facilities, systems and equipment, as connected together, perform effectively and reproducibly based on the approved process method and product specification.
EU GMP Guide, Annex 15
“The documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.”
Timing of the PQ
The PQ follows the completion of the OQ. It always takes place before process validation or cleaning validation. As a rule, it concerns complex, connected systems – for example a pharmaceutical production plant, a filling machine or purified water systems.
Test criteria of the PQ
The tests are based on the approved product specification and the requirement specification. On this basis, a placebo test is carried out, for example. Performance parameters with value ranges as well as upper and lower limits serve as criteria, such as:
Completing the qualification
At the end of the qualification work, a comprehensive report is customary. It documents all steps – from the risk analysis through DQ, IQ and OQ to the PQ.
The qualification process at a glance
- 1RA – Risk analysisIdentify and assess risks before the design is fixed.
- 2DQ – Design qualificationProof that the design is suitable for the intended purpose.
- 3IQ – Installation qualificationVerification of the installation against the order documents.
- 4OQ – Operational qualificationVerification of the intended functionality.
- 5PQ – Performance qualification (this page)Proof of the required performance in operation.
SEEFRIED Verfahrenstechnik GmbH supports you with the documentation and verification of the performance qualification – and, if required, with all other qualification steps.
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.