We are always ready for any changes
The Quality management system is certified in accordance with GLP and ISO 9001: 2015
The main aim of our organization is a high degree of satisfaction and the formation of sustainable consumer confidence
Quality service is:
Strict adherence to the Principles of Good Laboratory Practice and ISO 9001
- Regulated process of performing research work
- Development of regulatory documents
- Study-based inspections
- Facility-based inspections
- Process-based inspections
The quality service team is highly qualified specialists, which allows us to ensure the high quality of the work performed
- Khodko S.V., Makarova M.N., Makarov V.G., Salynov S.S., Rodionova N.V. Determination of the critical phases of the experimental research using laboratory animals: risk analysis. Vedomosti Nauchnogo tsentra ekspertizy stredstv meditsinskogo primeneniya = The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. – 2021, Vol. 11(3). – 193-201 https://doi. org/10.30895/1991-2919-2021-11-193-201 Abstract. Critical phases (stages) of preclinical studies are those procedures or types of research activities whose accurate and correct implementation is a prerequisite for obtaining valid and reliable results. Russian and foreign standards require determination of the critical phases of each individual study by quality assurance staff based on checking the study protocol (plan). The aim of the study was to identify critical phases typical for most preclinical studies, and assess the potential risks during inspections. Materials and methods: the study was carried out by analysing the types and consequences of failures. Numerical parameters of risks were analysed for each critical phase of the preclinical study identified by quality officers of the Joint Stock Company “Scientific and Production Association ‘HOME OF PHARMACY’”. Results: it was discovered that incorrect implementation of a procedure constituted a potential failure at all the identified critical phases, and a potential consequence was acquisition of low-quality data. A combination of incorrectly implemented procedures at two or more critical phases could pose an unacceptable risk and lead to complete loss of data or failure to process data, and, as a result, the need to repeat the study. Conclusions: the highest risk was identified for such critical phases as preparation and administration of final doses of test samples, performance of physiological tests, collection of biological material samples, and handling of biological material samples by other relevant departments. Summarising the data obtained on the risks of all the critical phases, it can be concluded that risk action should take the form of regular inspections by the quality assurance staff and the study director. By adjusting the frequency of inspections, the risk of each critical phase can be made insignificant [Full text is available in Russian].
- Makarova M.N. Tekhnologicheskie protsessy v vivarii i pitomnike – kak obespechit’ kachestvo?: materialy VIII konferentsii assotsiatsii spetsialistov po laboratornym zhivotnym (Rus-LASA). Pushchino.1-3 October 2020.
- Makarova M. Audit of Preclinical research center. Main directions. Laboratory Animals for Science. – 2019, № 1. – С. 1-10. https://doi.org/10.29296/2618723X-2019-01-05 SUMMARY. 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 [Full text is available in Russian].
- Bondareva E., Makarova M., Kovaleva M., Khodko S., Makarov V. Regulatory framework experimental biological clinics (vivaries) and nursery for laboratory animals. Laboratory Animals for Science. – 2018, №4. – P.1-16. https://doi.org/10.29296/2618723X-2018-04-08 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 [Full text is available in Russian].
- Burova E.D., Khod’ko S.V., Gushchina S.V., Makarova M.N., Makarov V.G. Risk management for quality assurance of preclinical drug research // Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. – 2017. – Vol. 7, No. 1. – P. 25-32.
- Shedko V.V., Gushchin J.A., Muzhikyan A.A., Makarova M.N. Retrospective analysis of histological archive // Development and registration of medicinal products. – 2016, № 3. – P. 162-165.
- Avdeeva O.I., Makarenko I.E., Makarova M.N., Shekunova E.V., Kashkin V.A., Makarov V.G. Harmonisation of research for the acute toxicity in accordance with Russian and international requirements // International Bulletin of Veterinary Medicine. – 2015, №1. – P. 103-109.
- Selezneva A.I., Makarova M.N., Rybakova A.V. Methods of randomization in the experimental animals // International Bulletin of Veterinary Medicine. – 2014, №2. – P. 84-89.
- Rybakova A.V., Makarova M.N. Marking and identification of laboratory animals for research projects // International Bulletin of Veterinary Medicine. – 2014, №4. – P. 81-90.
- Selezneva A.I., Makarova MN, Khodko S.V., Shikov A.N. Principles of Biomedical Research of quality control services involving animals // International Bulletin of Veterinary Medicine. – 2014, №3. – P. 173-181.