Audit Of Preclinical Research Center. Main Directions

М. Makarova, PhD, MD, Director JSC «Research-and-manufacturing company «Houm оf Pharmacy», Russia, 188663, Leningradskiy region, Vsevolozhskiy district, Kuzmolovskiy, st. Zavodskaya, 3. b. 245 Е-mail: makarova.mn@doclinika.ru

Abstract

The welfare of laboratory animals is essential to ensure quality of the experiments. Unfortunately, the few Quality Assurance Specialist of pharmaceutical companies are veterinarians, therefore could hardly fully evaluate these issues. The article discusses the key goals of the audit of a preclinical center, which uses laboratory animals. The following questions of audit are addressed: documents regarding veterinary care, implementation of laws of the Russian Federation, basic requirements concerning laboratory animals use in biomedical research are presented, basic standart operating procedures regulating animal welfare are discussed, the role of Animal Research Ethics Committee and its involvement in research protocol consideration in accordance with the principals of the 3 R and Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. Proper laboratory animal health monitoring provides good quality of research. The availability of well-trained competent staff involved in animal research is necessary for animal welfare providing. The research center should have the following specialists: veterinarian, animal technicians, well-trained technicians setting up scientific studies, specialists in pathology. In conclusion, there is an example of check-list of preclinical research center audit. Check-list includes key points of actual verification.

References

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