Qualifications in Plant Engineering
Pruess GmbH offers qualification as an own service for existing plants and as a sub-project during the design of new plants. In this case, although the qualification takes place as a final step before the handover to the customer, it is understood to be an integral component of the overall plant engineering project. Therefore, the requirements from the qualification are included in the planning from the start, which significantly reduces the later testing efforts and leads to a significantly leaner qualification with higher quality and the superior transparency of the scope of testing. The qualification can be carried out across all partial steps (DQ, IQ, OQ and PQ). Important: Pruess GmbH strictly separates the commissioning of a plant from its qualification. This means the qualification only occurs when it has been ensured that the qualification measures can be fulfilled in terms of the plant technology and organisation, so that deviations and inaccuracies can be ruled out.
The Pruess Concept of Qualification
The qualifications of the Pruess GmbH only cover the points to be qualified. In this respect, tests of a technical nature are carried out independently. It makes sense to create the qualification plans and the technical acceptance plans with only one tool which meticulously separates the areas to be tested into quality-relevant points and ones of a technical nature right from the start. The respective project phases, in which the individual steps of the tests are carried out, are ideally determined at this stage as well. This qualification concept enables a precise overview of all acceptance points, even if they overlap during the project phases. The two areas remain cleanly separated from each other.
The original document in a qualification is the "User Requirement Specification" (URS). It must include all of the essential quality elements and reduce possible GMP risks to an acceptable level. All other documents and elaborations throughout the validation life cycle are based on the URS. It is also a good basis for an invitation to tender.
Within the scope of the "Design Qualification", DQ for short, it is proven that the design of a plant complies with the requirements of "Good Manufacturing Practice" (GMP). The requirements of the URS should also be reviewed during the design qualification. If possible, the DQ takes place at the end of the design phase and is completed before the start of the construction. Depending on the project, the time of the DQ may vary: long-lead parts, for example, have to be ordered, the design cannot be qualified at this point in time. In these cases, the best approach must be discussed and defined in detail.
In the course of the "Installation Qualification" (IQ), the correct installation of components, instruments, etc. should essentially be checked against technical drawings and specifications, and the 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. The optimal time for an IQ, however, always depends on the risk analysis, the practicability and the type of test.
Once the "Installation Qualification" has been successfully completed, i.e. without critical deviations, the "Operation Qualification" (OQ) follows. In principle, this consists of a documented water flow test which demonstrates that the plant meets all the requirements defined in the URS – and in the other documents.
The last step in a qualification process is the "Process Qualification" (PQ). In some cases, however, it may be advisable to perform the PQ together with the functional qualification or the process validation. During the PQ, in the scope of the qualification, a product is manufactured in the system for the first time. All of the verifiable points that remain open at this point, as they are only verifiable with a product run, are now checked. This process is documented. The system can only be approved for validation when all the test points have been successfully completed and the product is within the specifications. For plants for the pharmaceutical industry, the completion of the PC is usually the latest point in time at which Pruess GmbH hands the plant over to the operator.