Quality assurance

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) and Good Clinical Practice (GCP). With their respective scopes of application, these quality assurance systems cover the translational approach in the institute’s spectrum of activities. The staff office “Quality Assurance” is responsible for putting into practice the relevant quality assurance programs.

GLP conformity of non-clinical safety studies

To ensure reliability and traceability of the data generated in non-clinical health and environmental safety studies, the GLP principles include, among others, the following requirements:

• Clear assignment of responsibilities within the test facility
• Meticulous planning and qualified performance of every study
• Complete documentation of all procedures and preparation of comprehensive reports

By means of study-based and facility-based inspections, the staff office “Quality Assurance” continuously monitors compliance with these principles in the institute’s departments of toxicology, safety pharmacology, and analytics.

The competent authority has certified GLP compliance for a broad range of studies as part of routine inspections for more than three decades. During the most recent inspection in January 2024, the integrity of the GLP studies conducted was once again confirmed. The established quality assurance system thus guarantees to all sponsors an internationally recognized quality standard in the institute’s departments performing non-clinical studies.

The ethical principles for biomedical research set out in the Declaration of Helsinki form the basis of the Good Clinical Practice (GCP) principles, which define the quality requirements for clinical trials. At Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, established quality assurance measures ensure that these requirements are met both in trials conducted on behalf of international sponsors and in investigator-initiated clinical research projects. The Quality Assurance staff unit supports investigators in fulfilling their responsibilities by closely accompanying the implementation of quality-relevant processes from a GCP perspective and by regularly reviewing the corresponding documentation. Sponsors assess the achieved level of quality as GCP-compliant.

At the Clinical Research Center Hannover (CRC Hannover), a facility jointly used by Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover Medical School, and the Helmholtz Centre for Infection Research, cross-project and coordinating quality assurance tasks are carried out by the Quality Assurance service unit. This ensures that high and consistent quality standards are maintained across the CRC Hannover facilities. The synergies created through the close scientific collaboration of the CRC partners therefore go hand in hand with ensuring the highest possible level of protection for all study participants and meeting the quality expectations of sponsors.