Qualification
in Plant EngineringPruess GmbH offers qualification both as a separate service for existing systems and as a sub-project in the design of new systems
Pruess Qualification with Concept
Pruess GmbH strictly separates the commissioning of a system from its qualification
At Pruess, we prioritize qualification measures to ensure impeccable technology and organization.
Our integrated engineering and qualification workflows allow for early ordering of long runners in compliance with regulations, even before the design phase is completed. Trust us to minimize deviations and inaccuracies while providing seamless project execution.
The Pruess concept of qualification
Qualifications by Pruess GmbH only cover the points to be qualified. Tests of a technical nature are carried out independently of this. It makes sense to create the qualification plans and the technical acceptance plans with just one tool, which meticulously divides the areas to be tested into quality-relevant points and those of a technical nature right from the start. The respective project phases in which the individual sub-steps of the tests are carried out are also defined at an early stage.
This qualification concept enables a precise overview of all acceptance points, even if these overlap during the project phases. The two areas remain clearly separated from each other.
URS
The “mother” of a qualification activities is the “User Requirement Specification”, or URS for short. It must include all essential quality elements and reduce any GMP risks to an acceptable level. All further documents and elaborations during the entire validation life cycle are based on the URS. It is also a good basis for a tender.
Design Qualification (DQ) is used to demonstrate that the design of a system meets the requirements of Good Manufacturing Practice (GMP). The requirements of the URS should also be verified during design qualification. If possible, DQ is performed at the end of the design phase and is completed before construction begins. However, the timing of the DQ may vary from project to project: For example, long runners must be ordered and the design cannot be qualified at this stage. In such cases, the best approach must be discussed and determined in detail.
Design Qualification
Installation Qualification
During “Installation Qualification” (IQ), the correct installation of components, instruments, etc. should be verified against technical drawings and specifications and instruments calibrated. In addition, the IQ provides for the recording of operating and work instructions as well as maintenance requirements. Ideally, it should take place during the FAT or SAT. However, the optimum time for an IQ will always depend on risk analysis, practicality and the nature of the inspection.
Once the Installation Qualification has been successfully completed, i.e. without any critical deviations, the Operation Qualification (OQ) follows. Basically, this is a documented water test to prove that the system meets all the requirements defined in the URS and other documents.
Operation Qualification
Process Qualification
Process qualification (PQ) is the final stage of qualification. In some cases, however, it may be advisable to perform PQ together with functional qualification or process validation. PQ is the first time a product is produced in the system as part of the qualification process. It checks all items that are open at this point because they can only be verified with a product run. This process is documented. The system can only be released for validation when all test items have been successfully completed and the product is within specification. In the case of systems for the pharmaceutical industry, the completion of the PC is usually the latest point at which Pruess GmbH hands over the system to the operator.
At Pruess, we prioritize qualification measures to ensure impeccable technology and organization.
Our integrated engineering and qualification workflows allow for early ordering of long runners in compliance with regulations, even before the design phase is completed. Trust us to minimize deviations and inaccuracies while providing seamless project execution.
For further information please send us an e-mail to info@pruess.gmbh or call us directly.
