Module and type qualification
New plant should be commissioned as quickly as possible. Existing systems should work just as they are meant to. Transparent evidence of all this has to be provided using GxP-compliant documentation. Pharmaserv’s qualification experts are deployed all over Germany.
Pre-qualification of modules
A module can be a single plant component, a functional unit consisting of several plant components or a functional part of a software architecture.
Standardised plant modules can be pre-qualified individually. The inspection is based on the design characteristics, interfaces, configurations and functions specified for the module. By cooperating with equipment manufacturers and adhering to procedures agreed with the respective manufacturer, the expenditure required can be reduced to a minimum. Identical modules can be integrated into a system more quickly and at less expense. The larger the number of pre-qualified modules, the faster a new system or process can be put into operation.
Qualifying equipment of the same type
With regard to type qualification, a type is a system which is specified by the manufacturer, designated accordingly and then produced in larger quantities with the same technical design and functions.
If a standard device such as a pharmaceutical product transport box, a refrigerator, a refrigerated transport vehicle or an incubator is pre-qualified, this basic qualification serves as evidence for all other equipment with the same design. Other devices of the same type need therefore only be subjected to a less detailed inspection. Provided a change control procedure is agreed with the manufacturer and implemented accordingly, this means that the effort and expense of qualifying equipment can be minimised without any loss of quality.