The qualification provides documentary evidence that the plant has been built as planned and is working within its technical specifications. The observance of the chorological order of the individual qualification phases is very important. We always observe GMP recommendations and directives and ensure that the specifications comply with GAMP and FDA regulations.
The procedure for the quality management of a project is fixed jointly with our client in a Project Quality Plan (PQP) at the beginning of the project. The PQP provides an overview of the project, project organisation, communication, document management, test procedures and procedure instructions to be applied, test phases and test documentation. The PQP also determines whether certain subcontractors will have to be audited in advance. If not, we will follow our strict requirements for the selection of suppliers.
Fig.1: Validation Master Plan
Planning and executing the qualifying activities are an integral part of our engineering process which starts with the User’s Requirements Specifications (URS) prepared by our client after the completion of a
GMP Risk Analysis (GMP-RA). We are available to provide support during the GMP-RA if requested. The next phase is the preparation of the design specifications (e.g.: FS, HDS, SDS, flow diagrams, parts lists, layouts, etc.) as part of the engineering process. In a
Design Review Process carried out jointly with our client, the conversion of the criteria from the URS will be documented during an approval process which concludes the
Design Qualification (DQ) phase.
The design documents constitute the basis for the construction of the plant and the programming of its automation process. Moreover, they form the basis for the following test phases. Our head office has the facilities to perform Factory Acceptance Tests (FAT) for vessels, process plant, skids, software, and control cabinets. Clients are welcome to attend if they wish.
After the successful realization of the project, the completed plant is ready for delivery. The installation and commissioning phases follow, and finally, predefined testing. During these tests the GMP-oriented aspects are checked for their function and installation. When the testing is completed, and with agreement of our client, the qualification documentation is prepared.
If required we will provide support for the subsequent Performance Qualification (PQ).