First Certificate of Drug Development Quality in the Baltics awarded to University of Tartu
The UT laboratory of the toxicology research group received the first Good Laboratory Practice certificate in the Baltic states. Ownership of the certificate and implementation of the stipulated principles allow the laboratory to participate in the development process of new drugs in cooperation with international pharmaceutical companies.
The development of new drugs, conducting surveys and related tests is strictly regulated by standards of the OECD, the European Medicines Agency and the International Conference on Harmonisation. The quality of research is guaranteed with the Good Laboratory Practice (GLP) principles developed by the OECD. There are only a limited number of laboratories in the European Union that correspond to the GLP requirements and own the GLP certificate: for example one laboratory has the certificate in Estonia, in Finland and in Belgium and four laboratories in Sweden.
The ownership of a GLP certificate is significant for a laboratory because only the research conducted under the GLP will be accepted in the subsequent drug development process. “The provision of research quality is inspected by and international inspection body. This certificate verifies that the research and toxicology laboratory of the toxicology group in the Department of Pharmacology of the Institute of Biomedicine and Translational Medicine corresponds to the OECD’s principles of Good Laboratory Practice and their research results are of good enough quality and acceptable in the drug development process," said Aleksander Žarkovski, Professor of pharmacology and toxicology in the University of Tartu.
The GLP certificate attributed to the University of Tartu applies in the field of industrial chemicals and toxicology testing of drugs. It proves that the results of tests conducted by UT’s researchers have sufficient quality, the personnel is competent, follows the required work organisation and ensures quality control.
Additional information: Aleksander Žarkovski, Professor of pharmacology and toxicology in the University of Tartu, phone: 737 4351, 523 1360, e-mail: aleksander.zarkovski [ät] ut.ee.