Medical Biotechnology

Committed to the highest quality

The Laboratories of the Main Department of Medical Biotechnology of the Fraunhofer Institute for Biomedical Engineering IBMT in Sulzbach has been GLP certified since mid-February 2019. In Saarland, the Ministry of the Environment and Consumer Protection is responsible for issuing a GLP certificate in accordance with § 19b (1) of the Chemicals Act.

Good Laboratory Practice (GLP) is an international set of rules designed to ensure the quality and comparability of test data from material investigations. In Germany, the principles of good laboratory practice are anchored in the Chemicals Act. According to the Chemicals Act, all non-clinical health and environmental safety assessments of substances and mixtures whose results should enable a risk assessment in an official procedure are subject to GLP. These tests must be carried out under strict quality assurance requirements. The test facilities performing such tests must work in accordance with the international GLP principles and have a corresponding GLP certificate. The GLP principles were developed by the OECD and placed on an international basis. This is how they found their way into European and national regulations. The Good Laboratory Practice is a quality assurance system and deals with the organizational process and the framework conditions of safety testing. These include, above all, the recording, archiving and reporting of these exams. The ultimate goal is to ensure that all data collected during an audit is fully and correctly included in the audit reports.

The GLP Federal Agency at the Federal Institute for Risk Assessment (BfR) is responsible for the coordination and harmonization of GLP-related issues in the national and international field as well as in the monitoring of certain GLP test facilities. BfR also publishes the list of GLP test facilities / test sites (www.saarland.de/GLP).