Risk-Based Approach to the Assessment of Sanitary Safety of Vivariums and Breeding Facilities, and Health Status of Personnel and Laboratory Animals

The paper discusses the system of managing risks arising during preclinical studies (risks for the health of personnel and laboratory animals, as well as risks associated with sanitation of premises) as a way to improve and control the efficiency of processes and the safety of facilities involved in preclinical studies.The aim of the study was to analyse the risk assessment system’s efficiency for improvement of drug safety assessment during preclinical studies in the context of animal care and use programmes.Materials and methods: the Failure Mode Effect Analysis (FMEA) method was used to assess the sanitary and hygienic conditions in laboratory animal facilities, as well as health status and welfare of laboratory animals and the attending personnel. The study checked the presence of pathogenic and opportunistic microflora as the main potential inconsistencies.Results: the risk assessment performed during monitoring of laboratory animal health, monitoring of surface cleanliness, and assessment of personnel health, helped to establish a list of the most dangerous pathogens that require stricter control. In order to reduce risks arising during preclinical studies, the following set of measures was proposed: monitoring of the living environment and health of laboratory animals, revision of therapeutic and preventive measures for laboratory animals (including adjustment of antibiotic treatment depending on antimicrobial resistance of microorganisms), monitoring of the personnel health status, taking measures to enhance the personnel vigilance with respect to their own health, prohibition to work at the premises for employees showing symptoms, control of how the employees showing symptoms observe the prohibition to work at the premises, organisation of periodic medical examinations for personnel having contact with laboratory animals.Conclusions: the risk-based assessment helped to identify the most dangerous potential inconsistencies (pathogenic and opportunistic microflora) and the necessary preventive measures to control and manage potential risk consequences