At different facilities, we also implement special standards and meet specific requirements, e.g. we hold a manufacturing license for pharmaceutical products according to the German Medicines Act. Moreover, relevant FDA guidelines, different GxP and standards-related product requirements are taken into account. This involves qualifying and validating production processes as well as buildings, clean-rooms and storage facilities according to precisely defined quality standards.

The validation approach is based on the classic V model and includes all required stages from DQ right through to PQ. Each individual production process is validated so as to ensure that the sum total of all these separate steps constitutes reliable production processes.

All tests that are determined by a product development process (TCC) and verified during the validation process are carried out at our production facilities. These include incoming inspection and process inspection as well as approval tests, which are carried out by a variety of measuring and testing facilities. If required, the relevant product tests can be integrated into our highly automated assembly lines so as to guarantee maximum product safety.

Gerresheimer Group's Medical Plastic Systems division installed systems for corrective and preventative error processing (CAPA). Our processes are revalidated at regular intervals. An established change control process ensures that the validated process conditions remain unchanged.

End-to-end documentation ensures that all quality measures are recorded and integrated into related certificates for our customers.

Bernd Stenzel
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