GLP Certificate for the Bioanalytical Laboratory of the MUG

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GLP Certificate for the Bioanalytical Laboratory of the MUG

28.10.2021

The Bioanalytical Laboratory of the Medical University of Gdańsk – a unit established under the Excellence Initiative – Research University program, operating at the Department of Biochemistry received on October 12, 2021 Certificate of Good Laboratory Practice. The decision was based on an inspection conducted on September 2, 2021, by inspectors from the Bureau of Chemical Substances.

Obtaining the certificate was preceded by several months of intensive work by the whole team consisting of Prof. Ryszard Tomasz Smoleński, Head of the Department of Biochemistry at the Medical University of the MUG, Paweł Olszewski, M.Eng., Laboratory Management Specialist, Agata Mechlińska, M.Sc., Quality Management Specialist, Katarzyna Smug, M.Sc., Analytics Specialist, Bartłomiej Łukasz, M.Sc., Analytics Specialist, and Natalia Literska, M.Sc., Technical Manager.


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Bio Lab Team: Paweł Olszewski, M.Eng., Bartłomiej Łukasz Ph.D., Agata Mechlińska, Eng.D., Katarzyna Smug M.Sc., Natalia Literska, M.Eng., Prof. Ryszard Tomasz Smoleński, photo Paweł Sudara/MUG

The Bioanalytical Laboratory’s profile includes qualitative and quantitative determination of compounds and their metabolites in biological samples of human or animal origin using high-performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) and immunoassays (ELISA).

According to the decision of the Bureau of Chemical Substances, the Laboratory meets the principles of GLP in the field of bioanalytical, pharmacokinetics, and chemical tests. This is the first certificate received in Poland by a university unit for the above-mentioned area of research. Until now, the list of certified research units included 5 universities from all over Poland, whereas currently only one university institution (except the MUG) still uses the quality system (out of the total number of 46 listed units, mainly from the private sector).

GLP certificate is a confirmation of a high level of quality and reliability of conducted research. Moreover, it authorizes the Laboratory to conduct preclinical and clinical research, which must be carried out in compliance with GLP standards. Having this kind of certificate is prestigious for the University and gives the possibility to win new partners for cooperation and clients for commercial research.

GLP Certificate (61.9 KB)