Institute for Transfusion Medicine and Gene Therapy

Quality Control

Department head: Dr. Marie-Christin Pauly

The quality control department is responsible for blood product testing in accordance with the German Medicines Act and includes the quality control laboratory and the blood donation laboratory.

Quality Control Laboratory
Head of Diagnostics: Isabella Klink

For routine quality control, regular checks are carried out randomly on all manufactured units in order to demonstrate compliance with the product specification. In addition, stability analyses are carried out at the end of the shelf life to provide evidence for the correct storage of the products. Furthermore, data on critical quality parameters is collected and submitted to the federal authority within the scope of evaluating change requests to the marketing authorization dossier. A list of diagnostic services provided by the Quality Control Laboratory can be found below.

Blood Donation Laboratory
Head of Diagnostics: Doreen Grundke

In the blood donation laboratory, samples of the donated blood are analysed for infectious diseases using serological detection methods and virus genome analyses. In the case of samples with atypical screening test results, the confirmatory tests are carried out in an external laboratory. Follow-up samples are also made from all blood donations, archived and re-examined if necessary.

Diagnostic Services of the Quality Control Laboratory