GXP – quality assurance according to international standards
Fraunhofer ITEM is striving to meet high quality standards with the services and products offered and to ensure maximum safety for trial subjects in clinical studies performed at the institute. Not only are the relevant legal regulations strictly complied with, but state of the art regulatory requirements are invariably taken into consideration. To guarantee that the work performed at Fraunhofer ITEM satisfies internationally accepted quality standards, Fraunhofer ITEM has implemented the GXP quality assurance systems. These include Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). With their respective scopes of application, these quality assurance systems cover the translational approach in the institute’s spectrum of activities. The central service unit “Quality Assurance” is responsible for putting into practice the relevant quality assurance programs.