The quality service verifies each study for compliance with GOST (Government Standard, All-Union state standard) no. 31883-2012 and GLP (Good Laboratory Practice) Principles.
The quality service:
– check stidies at all stages of research work,
– check the individual processes and manipulations,
– check the organization on the whole
in order to provide assurance that rooms, equipment, personnel, methods and documentation meet the standard requirements. Quality service has a documented quality assurance program confirming a compliance of the performed works to the principles of good laboratory practice.
Our quality of service specialists are regularly trained on quality management, improving their skills by implementing in practice the latest instructional techniques in the field of “good practices“.
In our organization, we developed and introduced about 350 standard operating procedures (SOPs). Working with SOPs is carried out continuously. Staff training on the standard operating procedures are conducted in accordance with the annual plan.
Our service quality experts have extensive experience in the development of standard operating procedures (SOPs), creating a list of required SOPs to perform certain technological or administrative action. Such work may be performed by us and by your order.
- 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. 173-81.
- 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 M.N., Rybakova A.V. Methods of randomization in the experimental animals // International Bulletin of Veterinary Medicine. – 2014, №2. – P. 84-89.
- 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.
- 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.
- 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.
- 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].
- 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].