Basic approaches to quality assurance of biological test systems in GLP-studies

M.A. Zaitseva, E.G. Potapenko, T.V. Kashina, A.B. Verveda

Institute of Toxicology of the Federal Medical and Biological Agency, 1 Bekhtereva St., St Petersburg 192019, Russian Federation

Е-mail: Zaytseva.m.a@toxicology.ru

Abstract

The main documents of Good Laboratory Practice (GLP – OECD Guide 1:1998 OECD Principles of good laboratory practice) includes the term as test system which can be as physical, chemical and biological and can be presented by laboratory animals, plants, bacteria, isolated organs, cells / cell structures. This article describes the biological test systems as laboratory animal’s maintenance.

The life conditions of laboratory animals and the processes for their health monitoring should satisfy both scientific considerations regarding research and take into account international and national legislation on animal welfare to comply for  Decree of the Chief State Sanitary Doctor of the Russian Federation of August 29, 2014 No. 51 on the approval of SP 2.2.1.3218-14 “Sanitary and epidemiological requirements for the design, equipment and maintenance of experimental biological clinics (vivariums)”. As a result of this process the compliance evidences should be received for the laboratory animals and for animal’s life conditions at the preclinical testing conducting. As a quality parameters the clinical and microbiological status should be assessed. The temperature, humidity, illumination, noise, air exchange rate, air gas composition. In order to reduce the level of microbial contamination and create conditions for preventing the spread of infectious diseases, it is necessary to regularly sanitize the test systems area, as well as to carry out disinfection, disinsection and disinfestation procedure. Feed, bedding and water are subject to mandatory quality control for composition and microbiological purity during the study. In this case, evidence must be obtained of the biological test systems compliance  to special requirements. The implementation of the program leads to the   animal health status  maintenance and guarantees the well-being of experimental animals, should  include control of laboratory animals, vivarium environment, animal rooms or cages, additional materials, as well as an action plan in case of detection of a disease or distress.

Full text avaliable in Russain only

 

References

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