PQ - Process Qualification

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.

Back to DQ – Design Qualification