Regulatory Framework Experimental Biological Clinics (Vivaries) And Nursery For Laboratory Animals

E. Bondareva(1), M. Makarova(2), M. Kovaleva(3), S. Khodko(2), V. Makarov(1) 1-Institute of pre-clinical studies 188663, Leningradskiy region, Vsevolozhskiy district, Kuzmolovskiy, 3, Zavodskaya st., b. 245, Russia; 2-Scientific-Production Organization «Houm оf Pharmacy» 188663, Leningradskiy region, Vsevolozhskiy district, Kuzmolovskiy, 3, Zavodskaya st., b. 245, Russia; 3-St. Petersburg Institute of Pharmacy, 188663, Leningradskiy region, Vsevolozhskiy district, Kuzmolovskiy, 3, Zavodskaya st., b. 245, Russia Е-mail: bondareva.ed@doclinika.ru

Abstract

Summary. The test center is a business entity and in its activities it should be guided by national regulatory documents. Speaking about separate structural divisions, such as a nursery and a vivarium, it is necessary to consider not only national, but also international ND and other manuals. Medical and biological research and obtaining adequate undistorted results require a specially equipped vivarium, trained personnel, and specialized programs for the care of laboratory animals. In premises for keeping animals, proper parameters of temperature, humidity, air exchange and illumination should be observed in accordance with the requirements of regulatory documents. Microclimate parameters have a significant impact on the state and life processes of animals, which directly affects the conduct of experimental studies and obtaining reliable data. Proper maintenance and use of laboratory animals for preclinical studies will allow for a higher quality of the animals themselves and, as a result, obtaining more reliable research results. An organization that conducts preclinical research cannot focus only on Federal Law No. 61 «On the Circulation of Medicinal Products» and on GOST 33044-2014 Principles of Good Laboratory Practice. The activity of such an object as a vivarium or nursery of laboratory animals is a complex set of activities. In such a complex should be considered: Protection of personnel and labor protection associated with the accumulation of hazardous substances in the air of the working area (ammonia, formalin, wool and dust from animals, etc.), with the risk of occurrence and spread of epizootic diseases; Ensuring the well-being and health of laboratory animals in order to respect not only the purity of the experiment, but also ethical principles; The inevitability of the generation of hazardous waste (medical waste and biological waste, plums of chemicals from research laboratories, waste of medicines, etc.); The proper handling of drugs. This article provides a brief overview of the national and international regulatory documents governing the vivarium, taking into account all the most important elements that require control at the legislative level.

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