Laboratory of quality control of biological preparations is part of the Zabolotny Institute of Microbiology and Virology, NAS of Ukraine and went since 2009.
The Laboratory carries out control over the quality and safety of medical immunobiological preparations, such as probiotics, adjuvant (cell lysates), from donor’s blood plasma preparations: immunoglobulins, albumins, recombinant immunobiological preparations (interferons, interleukins), etc.
The laboratory has 15 highly skilled researchers. The chief – Dr. T.M. Golovach, the head of Microbiology sector - Dr. O.A. Poltavska, the head of sector of virological and immunochemical studies - Dr. N.V. Nesterova, the head of sector of physico-chemical studies – Dr. A.M. Ostapchuk. Authorised person of quality control – corr.-member of NAS of Ukraine - N.K. Kovalenko.
- is certified by the State Service of Ukraine on drugs for the right to control the quality and safety of medicines in compliance with criteria of good laboratory control of medicines according to the "Procedure for certification of laboratories for quality control and safety of medicines", approved by order of the Ministry of Health of Ukraine from 14.01.2004 №10. Certificate №152 from 16.08.2012, valid until 08.18.2015.
- meets the criteria for certification of test laboratories and has been certified by SE "Ukrmetrteststandart" according to the Law of Ukraine "On metrology and metrological activity" for the right of measurements of objects, according to industry of accreditation. Certificate №PT-220/12 from 19.06.2012, valid until 18.06.2015.
- is authorized to work with infectious agents of III-IV groups of pathogenicity provided by Kyiv municipal controlled-access commission according to DSP 9.9.5.-064-2000 "The procedure of permits issuance to work with microorganisms of I-IV groups of pathogenicity for humans and with recombinant DNA molecules". Resolution № 37-12 from 31.05.2012, valid until 29.05.2017.
The work is regulated by "Regulations on Laboratory" and "Guidelines for quality." General infarmation concerning the Laboratory, forms of drugs that can be tested, test methods, a list of measurements and tests, information about experts, condition of the main premises, the availability of documentation, etc. are mentioned in "Passport of the Laboratory." The premises of the Laboratory are located on two floors of the new building of the Institute. On the third floor there are sectors that monitor the biological quality. On the fourth – there is a sector that monitors physical and chemical characteristics.
D03680 MSP, Kyiv
154 Zabolotnogo str.
Tel. (044) 526-23-29.
Fax (044) 220-11-84,