abe engineering GmbH
 abe engineering GmbH


competence, quality and planning

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The qualification is an elementary component of the quality assurance system for pharmaceutical manufacturer. It shall prove that the used plants are suitable for its purposes and guarantee that the produced drugs show the required quality. The qualification is therefore a basic factor for the drug safety.

With the qualification you test documented that equipment (hard & software) which serves for the putting into action of the processes have the functionality specified before.


Our offer

Design Qualification (DQ)

We examine, whether the construction plans agree with the customer specification.

In a first meeting we define customer wishes and prepare validation-strategies. After that we analyze in a design review the construction, specification and the project risks. After that we fix the basic conditions for the series of tests. 

Installation Qualification (IQ)

We document a proof, that the equipment corresponds to the demands made to it with respect to identity, installation, guideline conformity and documentation.

The equipment is examined on cover with the qualification profile (user requirements) and on a proper installation.

Operation Qualification (OQ)

We check and document your facilities, plants and equipments. We make sure that the installations are carried out so as planned and your equipments duly work. The function qualification starts after a successful completion of the installation qualification.

Performance Qualification (PQ )

You will get a completely documented verification from us, that your facilities or plants work effectively and reproducibly approved process-method and product-specifications.

We check the interplay of all of the units and guarantee a representative documentation.


  Last Update: 17. Nov 2006

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