The Quality Service a team of highly qualified specialists with extensive experience in research work, which allows ensuring the high quality of work performed. Our specialists regularly undergo training in quality management, improving their qualifications, introducing in practice the latest methodology in the field of GxP.
Regulatory documents for work of the Quality Service:
The Federal Law №61-FZ of 12.04.2010 «On Circulation of Medicines».
The Order of the Ministry of Health of the Russian Federation of April 1, 2016, №199n «On the Approval of the Rules of Good Laboratory Practice»
Resolution № 81of EAEU “Concerning adoption of the Good laboratory practice of EAEU in the field of drug circulation”
GOST 33044-2014 “Principles of Good Laboratory Practice”
GOST 31883-2012 “Principles of Good Laboratory Practice (GLP). Quality assurance in the application of GLP principles”
GOST 7.32-2017 “System of standards on information, librarianship and publishing. The research report. Structure and rules of presentation”
Function of Quality Service:
In accordance with regulatory standards, there are three types of inspection defined by the quality assurance program:
Monitoring of studies;
Monitoring of experimental (research) center;
Monitoring of processes.
to monitor compliance with the regulatory requirements of the premises, equipment, personnel, methods and documentation.
The Quality Service has a documented Quality Assurance Program confirming the compliance with the principles of GLP.
About 150 standard operating procedures (SOP) have been developed and implemented in our organization. Work with SOP is ongoing. It is also possible to create SOPs for your requirements.
“RMC “HOME OF PHARMACY” always opens to monitoring and auditing of the research by various regulatory entities. Various audits of the “RMC “HOME OF PHARMACY” show that the organization complies with international quality standards for organizing and conducting preclinical studies according to the criteria of GLP.
Publications by topic:
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-2018-04-08SUMMARY. 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-2019-01-05SUMMARY. 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].
