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), preparations from donor’s blood plasma: immunoglobulins, albumins, recombinant immunobiological preparations (interferons, interleukins), etc.
The chief laboratory is Dr. S.D. Zagorodnya, authorised person of quality control – corr.-member of NAS of Ukraine N.K. Kovalenko.
The structure of LQCBP of IMV of NAS of UKRAINE:
- Sector of Microbiological Researches
- Sector of Molecular-Biological and Genetic Researches
- Grup of Phisic-Chemical Researches
In the Laboratory works 15 highly skilled researchers.
Certificates of accreditation / attestation of the Laboratory:
- is certified by the State Service of Ukraine on drugs at the right to control the quality and safety of medicines in compliance with criteria of laboratory control of medicines according to the "Procedure of 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 №393 from 12.03.2019, valid until 26.02.2022..
Branch of attestation
- 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 branch of attestation. Certificate №PT-533/15 from 30.12.2015, valid until 30.12.2018..
- 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".
- License №40 dated 07.07.2016 for the purchase, storage and destruction of precursors (list 2 of table IV and list 1 of table IV) issued by the State Service of Ukraine for Drug Control (valid until 07.07.2021).
- The work is regulated by "Regulations on Laboratory" and "Guidelines for quality." General information 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, etc. are contained in "Passport of the Laboratory."
Zabolotnogo str., 154, 03143 Kyiv, Ukraine
Tel. (+38044) 294-69-73 and (+38044) 294-69-65
Fax (+38044) 294-69-73