Importance of the PQ – Process 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. (EC-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 rated
- Agreed performance parameters / Efficiency outputs
- Number / pieces
- Accuracies / Tolerances
- etc.
SEEFRIED Verfahrenstechnik GmbH supports you with the compiling of documentation and verification of the PQ – Process 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 the Process Qualification, as well as the aforementioned final report. We will be pleased to assist you with all the steps mentioned.