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Qualification

Such more than just service

QualifizierungModern production plants in the field of medical and pharmaceutical technology are subject to the strict requirements of the US Food and Drug Administration (FDA) and thus a corresponding validation of the manufacturing process.

The aim of this qualification is to control the manufacturing process (process validation) and ensure a constant product quality. At the same time, this qualification provides proof that all system components are working perfectly under production conditions and able to produce the specified results.

The execution of this qualification and the specifications of the qualification documentation are based on the internationally recognized GAMP 4 Guidelines (Good Automated Manufacturing Practice).

On request, FLG is able to supply the respective qualification documents for DQ, IQ, OQ and carry out the necessary inspections and test runs required for qualification.