ISO/IEC 17025
State Enterprise on the Right of Economic Management “Masgut Aikimbaev National Scientific Center for Particularly Dangerous Infections” of the Ministry of Health of the Republic of Kazakhstan
Testing laboratory, Department of biological and technological control.
The quality control laboratory was organized in 1949 in connection with the beginning of development of the production of plague vaccine in the Kazakh SSR.
The laboratory has permission to work with microorganisms of pathogenicity groups I-IV.
The laboratory has been accredited by the National Accreditation Center of the Republic of Kazakhstan since 2009 (14 years) for compliance with the requirements of GOST ISO/IEC 17025-2019.
Information about the laboratory and the scope of accreditation of the IL NSCOIOI are posted on the website of the NCA RK, as well as on the website of the EAEU in the list of laboratories of Kazakhstan.
IL is the only accredited laboratory in the Republic of Kazakhstan that evaluates the effectiveness of insecticides on certain types of arthropods.
The task of the division: creation and provision of a quality control system at all stages of production of medical immunobiological preparations (MIBP) produced by the NCOOI in order to prevent the production and release of low-quality products, as well as conducting control tests of bacterial vaccines, diagnostic bacteriophages, nutrient media, test systems and erythrocyte diagnostics, disinfectants and antiseptics, insecticides, personal protective equipment, toxicological tests within the scope of IL accreditation.
Possibilities:
– within the scope of accreditation, testing of bacterial vaccines (including for animals), test systems, diagnostic preparations, disinfectants and disinfestation agents;
– participation in trials of new immunological medicinal and diagnostic drugs;
– participation in interlaboratory comparison tests,
– determination of the harmlessness, immunogenicity, toxicity of medicinal immunobiological preparations of all pathogenicity groups;
– determination of the effectiveness and toxicity of new disinfection and disinfestation agents;
– testing of personal protective equipment for compliance with the requirements of Technical Regulation CU 019/2011 (for permeability).
JSC “Scientific Center of Anti-Infective Drugs”
The Testing Center of JSC Scientific Center for Anti-Infective Drugs is accredited for compliance with the requirements of the interstate standard GOST ISO/IEC 17025–2019 (ISO/IEC 17025:2017) “General requirements for the competence of testing and calibration laboratories”. Registered in the register of accreditation entities under number KZ.T.02.E1034 from 05/25/2022 to 02/25/2027. The objects of accreditation of the Testing Center are medicines, including those for veterinary use, feed additives, antibiotics, disinfectants, medical devices, personal protective equipment, culture media, water (drinking, purified, natural), products of the chemical and related industries (other chemical products), as well as food products.
The testing center of JSC Scientific Center for Anti-Infective Drugs has been included in the Kazakhstani part of the Unified Register of Conformity Assessment Bodies of the EAEU.
The research base of JSC NCPP includes a modern complex of equipment for the maintenance and use of outbred and inbred laboratory animals of the SPF category in research.
JSC “NCPP” is accredited as a subject of scientific and (or) scientific and technical activity. The scientific center has received 6 state licenses, including for medical activities, handling of radioactive substances, devices and installations containing radioactive substances, production of veterinary drugs, production, processing, acquisition, storage, sale, use, destruction of poisons, pharmaceutical activities, activities related to the circulation of precursors.
State Enterprise on the Right of Economic Management “Research Institute for Biological Safety Problems” of the Ministry of Health of the Republic of Kazakhstan
The testing laboratory “Control of technology and biopreparations” is a structural unit of the State Enterprise on the Right of Economic Management “Research Institute for Biological Safety Problems” of the Ministry of Health of the Republic of Kazakhstan.
The testing laboratory is accredited in the State System of Technical Regulation of the Republic of Kazakhstan, by the Accreditation Authority of the National Accreditation Center LLP (accreditation certificate No. KZ.T.08.1389, date of issue from November 09, 2018).
The testing laboratory checks the quality of biological products manufactured by the institute’s divisions. Organizes control over compliance with the production technology of products for animal husbandry and veterinary medicine. Participates in the development of technological conditions for veterinary products, gives an opinion on the normative and technical documentation developed in the Research Institute of Biotechnology, Biotechnology and Biotechnology or received from other institutions. Organizes and carries out work on the approval of normative and technical documentation in the Ministry of Agriculture of the Republic of Kazakhstan, the State Standard of the Republic of Kazakhstan and Kazpatent of the Republic of Kazakhstan. Carries out work on the introduction of biological products through industrial testing. Develops issues of designing inactivated vaccines, technologies for their experimental and semi-industrial production. Conducts epizootological monitoring and laboratory examination of pathological material received from various regions of Kazakhstan, as well as registration tests of biological products received from the Republican Veterinary Laboratory of the Ministry of Agriculture of the Republic of Kazakhstan.
JSC “Kazakh Scientific Research Veterinary Institute”
The testing center of the Kazakh Research Veterinary Institute LLP is accredited in the accreditation system of the Republic of Kazakhstan for compliance with the requirements of GOST ISO/IEC 17025-2019 “General requirements for the competence of testing and calibration laboratories (TC)” (No. KZ.T.02.1395 dated October 2, 2018).
Information data about the IC:
Objects of conformity assessment: Testing center in the field of veterinary diagnostic and molecular genetic research, determination of the quality of veterinary drugs, compliance with the requirements of technical regulations of the Customs/Eurasian Union.
Testing laboratories:
- Laboratory of Bacteriology
- Virology laboratory
- Brucellosis laboratory
- Laboratory of Parasitology and Mycology
- Laboratory of Molecular Genetics and Food Safety.
Scope of accreditation:
– Veterinary diagnostic studies (51 indicators)
– Molecular genetic studies (3 indicators)
– Determination of the quality of veterinary drugs (15 indicators)
– for compliance with the requirements of technical regulations of the CU/EAEU (19 indicators).
The scope of accreditation is provided in the technical regulation information system (e-KTRM).
The combined ILAC MRA mark has been received. The use of these marks confirms that the activities of the Institute’s testing center comply with international standards and regulations.
The testing center is provided with the material and technical base necessary for the proper implementation of laboratory activities in accordance with the scope of accreditation (measuring instruments, testing equipment, auxiliary devices, software, reference strains of microorganisms with typical properties, standard samples, reagents, consumables, etc.).
LLP “NAC “Biomedpreparat”
The laboratory of NAC Biomedpreparat LLC is accredited for compliance with the requirements of GOST ISO/IEC 17025-2019. It is located in Stepnogorsk, Akmola region. Registered in the register of accreditation entities under number KZ.T.03.2445 from 12/30/2022 to 12/30/2027.
According to the scope of accreditation, the laboratory conducts:
- water analysis (drinking water from centralized domestic and drinking water supply, natural water (reservoirs, precipitation), mineral drinking medicinal water, medicinal table water and natural table water, waste water);
- analysis of minerals: iron ores, concentrates, agglomerates, copper concentrates – to determine more than 6 elements separately (content of Au, Ag, Fe, Pb, Zn, Cu) and moisture content;
The studies are carried out in accordance with GOST 32221-2013 using the flame atomic absorption method.
- GLP
JSC NCPP is one of the organizations operating in the Republic of Kazakhstan, accredited by the Federal GLP Bureau of the Federal Republic of Germany represented by the executive body – the Federal Institute for Risk Assessment (Das Bundesinstitut für Risikobewertung (BfR); gemäß/ according to 19As 2 33 Chemikaliengesetz) for compliance with the principles of Good Laboratory Practice of the Organization for Economic Cooperation and Development (OECD GLP) (certificate issued on March 31, 2014).
In 2018, JSC NCPP successfully passed re-accreditation and, having a certificate of compliance with the OECD GLP Principles, is able to legitimately conduct tests in the field of in vitro mutagenicity research and physicochemical tests. Accreditation of the laboratory according to GLP standards means that the results obtained at JSC NCPP can be automatically accepted by other OECD member countries.
In addition, JSC NCPP is accredited in the field of testing medicinal products for technical competence in accordance with the ISO/IEC 17025 standard, accreditation certificate KZB8D5F2740A73B90F, registered in the register of accreditation entities No. KZ.T.02.E1034 dated May 25, 2022. Studies conducted at JSC NCPP on the safety of tested and tested chemical substances and mixtures included in pesticides, feed additives, veterinary drugs, food additives, medicines, cosmetics and industrial chemicals comply with the international OECD GLP principles.
The testing base of JSC NCPP is included in the Unified Register of Testing Laboratories of the EAEU ( http://www.eurasiancommission.org/ru/docs/Pages/Il_OS.aspx ).
Currently, documentation is being prepared for re-accreditation according to the international GLP standard.