Quality assurance and legal disclaimer
Good quality and constant improvements are important for our patients. To aid this we have implemented a quality management and quality assurance system, which supports us in the laboratory and in direct contact with the patients.
Cell based immunotherapies are drugs and their manufacture including the laboratories are strictly monitored.
Our laboratory is a Good Manufacturing Practice (GMP) facility. This includes a quality assurance system that fulfills the standards of the pharmaceutical industry.
Laws and national and European guidelines are incorporated into our quality assurance system. The quality assurance officers together with our employees are responsible for the ongoing implementation and optimization of the system.
We have appointed Mrs. Dipl. Med. Ute Leib as our transfusion physician for the Praxisgemeinschaft für Zelltherapie Duderstadt GmbH & Co. KG in accordance with German transfusion laws.
In addition we are regularly being audited and controlled by the local authorities, which are:
- Gewerbeaufsichtsamt Braunschweig (Factory inspectorate Brunswick)
- Ärztekammer Niedersachsen (Board of physicians Lower Saxony)