Лабораторія з контролю якості біологічних препаратів - ІМВ НАН України 🇺🇦

The laboratory is included in the list of recommended laboratories authorized by the State Service of Medicines and Narcotics Control of Ukraine to carry out work on the quality control of medicinal products (Addendum to the order of the State Medical Service dated 14.11.16 No. 543).

The head of the laboratory is Ph.D. Svitlana Zagorodnya 

STRUCTURE OF THE LABORATORY FOR QUALITY CONTROL OF BIOLOGICAL PREPARATIONS OF THE IMV NAS OF UKRAINE

  • Sector of microbiological research  
  • Sector of molecular biological and genetic research 
  • Group of physical and chemical research 
  • Vivarium 

The laboratory for quality control of biological preparations is part of the Institute of Microbiology and Virology named after D.K. Zabolotny National Academy of Sciences of Ukraine and has been working since 2009.

15 highly qualified scientific employees work in the laboratory.

Certificates of accreditation/attestation

  • certified by the State Service of Ukraine for Medicinal Products for the right to control the quality and safety of medicinal products in accordance with the criteria for proper laboratory control of medicinal products in accordance with the "Procedure for the attestation of laboratories for quality and safety control of medicinal products", approved by the order of the Ministry of Health of Ukraine dated 14.01.2004 No. 10. Certificate No. 393 dated March 12, 2019, valid until February 26, 2022 [in Ukrainian].
  • meets the criteria of certification of measuring laboratories and certified by SE "Ukrmetrteststandart" according to the Law of Ukraine "On metrology and metrological activities" for the right to measure objects, according to the field of certification. Certificate No.PT-533/15 dated 12/30/2015, valid until 12/30/2018 [in Ukrainian]
  • has permission to work with causative agents of III-IV pathogenicity groups, provided by the Kyiv City Regime Commission in accordance with DSP 9.9.5.- 064-2000 "Procedure for Issuing Permits for Work with Microorganisms of I-IV Groups of Pathogenicity for Humans and Recombinant DNA Molecules".
  • License series No. 40 dated July 7, 2016 [in Ukrainian]. for the acquisition, storage, destruction of precursors (list 2 of Table IV and list 1 of Table IV), issued by the State Drug Control Service of Ukraine (validity period - until 07.07.2021).
  • Work is regulated by "Regulations of the Laboratory" and by "Quality guideline". General information about the Laboratory, the forms of drugs that can be analyzed, test methods, a list of measuring and testing equipment, information about specialists, the condition of the main premises, availability of NTD, etc. are indicated in the "Laboratory Passport".

Contacts

    03143 Kyiv
    St. Zabolotny 154.
    Ph.(044) 294-69-73 or (044) 294-69-65. 
    Fax  (044) 294-69-73,
    e-mail: svetazagorodnya@ukr.net