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.
Ourquality ofservicespecialistsare regularly trainedonquality management, improvingtheir skillsby implementingin practicethe latestinstructional techniquesin the field of“good practices“.
In our organization,we developed and introducedabout 350standard operating procedures(SOPs). Working withSOPsis carried out continuously.Staff trainingon thestandard operating proceduresare conducted in accordancewith the annual plan.
Ourservicequalityexpertshave extensive experiencein the development ofstandard operating procedures(SOPs), creating alist of requiredSOPstoperform certaintechnologicalor administrativeaction. Such workmay be performedby us andbyyour order.
Members of the quality service have auditor certificates of internal quality management system audits on a compliance to the state standard GOST ISO 9001-2011 (ISO 9001:2008).
Publications by topic:
Selezneva AI, Makarova MN, KhodkoS.V., Shikov AN Principles of Biomedical Research of quality control services involving animals // International Bulletin of Veterinary Medicine. -2014, №3. -P. 173-81.
Rybakova, AV, Makarova MN Marking and identification of laboratory animals for research projects // International Bulletin of Veterinary Medicine. -2014, №4. -P. 81-90.
Selezneva AI, Makarova MN, AV Rybakova Methods of randomization in the experimental animals //International Bulletin of Veterinary Medicine. -2014, №2. -P. 84-89.
Avdeeva OI, Makarenko IE, Makarova MN Shekunova EV, Kashkin VA, Makarov VG 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 VV, Gushchin JA, Muzhikyan AA, Makarova MN Retrospective analysis of histological archive // Development and registration of medicinal products. -2016, № 3. C. 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.