Quality

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.

 

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 service unit “Quality Assurance” continuously monitors compliance with these principles in the institute’s departments of toxicology, safety pharmacology, and analytics. During the past two decades, the competent authorities have performed regular inspections and certified the institute’s GLP conformity for a broad range of studies. On the occasion of the last inspection in December 2014, the integrity of the GLP studies performed was once again confirmed. The established quality assurance system thus guarantees to all sponsors a recognized quality standard in the institute’s non-clinical departments.

Statement of GLP compliance

 

GCP standard of clinical trials

 

The ethical principles for biomedical research laid down in the Declaration of Helsinki form the basis of the GCP principles describing the quality standards to be met in clinical trials. At Fraunhofer ITEM, a broad range of measures ensures that these requirements can be met both in trials falling under the German Drug Act and performed on behalf of international sponsors and also in clinical research projects. The service unit “Quality Assurance” assists the clinical investigators in fulfilling their responsibilities by closely monitoring implementation of the quality-relevant processes under aspects of GCP and by routinely checking the relevant documentation. Both the monitoring authority and the institute’s sponsors have assessed the quality level reached to be GCP-compliant. 

During setup of the Clinical Research Center Hannover (CRC Hannover), co-operated as a Fraunhofer research institution by Fraunhofer ITEM, the Hannover Medical School (MHH) and the Helmholtz Center for Infection Research (HZI), the service unit “Quality Assurance” assumed lead responsibility in the establishment of a joint quality assurance system for the facilities used by the cooperation partners performing clinical trials according to GCP. During routine operation of the CRC Hannover, the service unit “Quality Assurance” is performing cross-project and coordinating tasks in the field of quality assurance, thereby contributing to a steady high level of uniform quality standards in the facilities of the CRC Hannover. The synergies resulting from the scientific cooperation of the partners to the CRC Hannover thus go hand in hand with guaranteed maximum protection of all trial subjects and fulfillment of sponsors’ quality requirements.

 

Fraunhofer ITEM GMP facilities

 

All manufacturing and quality control steps for investigational medicinal products to be used in clinical trials – including challenge agents – are subject to stringent GMP requirements.