<\/p>\n\n\n\n
The State Research Laboratory for Drug Quality Control at the State Institution \u00abMarzieiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine\u00bb has been certified by the State Service of Ukraine on Medicines and Medical Devices (certificate of certification No. 603 dated May 29, 2025), and accredited by the National Accreditation Agency of Ukraine for compliance with the requirements of DSTU EN ISO\/IEC 17025:2019 \u201cGeneral Requirements for the Competence of Testing and Calibration Laboratories,\u201d and the laboratory\u2019s quality management system is certified by the Ukrainian Institute of Standards as compliant with the requirements of DSTU EN ISO 9001:2018 and has been prequalified by the WHO since 2016.<\/p>\n\n\n\n
As of March 4, 2025, the Institute\u2019s laboratory has been included in the List of Recommended Laboratories authorized by the State Service of Ukraine on Medicines and Drug Control to conduct quality control of medicinal products.<\/p>\n\n\n\n
Audits are conducted regularly at the laboratory; in April, two external audits were conducted at the Institute\u2019s laboratory by clients, namely JSC \u201cFarmak,\u201d Ukraine, and LLC \u201cIstpharm,\u201d Ukraine, in accordance with quality agreements.<\/p>\n\n\n\n
On April 7, authorized specialists from JSC \u201cFarmak\u201d conducted an audit of the laboratory to verify the scope of its material and technical resources, verify compliance with regulatory standards and Farmak JSC requirements, and assess the laboratory\u2019s ability to consistently provide services of appropriate quality for its designation as a contract laboratory to conduct physicochemical, biological, and microbiological testing of its products. The audit was conducted in accordance with all aspects of the laboratory\u2019s quality management system; sample traceability was verified from registration to transfer for disposal, and all issues regarding the validation of the obtained data were reviewed. Based on the audit results, the Institute\u2019s laboratory was recommended for inclusion in the list of contract laboratories of JSC \u201cFarmak.\u201d<\/p>\n\n\n\n
On April 17, an audit was conducted at Istpharm LLC, Ukraine, to assess the compliance of contract laboratories\u2019 activities with the requirements of ST-N Ministry of Health of Ukraine 42-4.0:2020 Guidelines. Medicinal products. Good manufacturing practice and DSTU ISO\/IEC 17025:2019 \u201cGeneral requirements for the competence of testing and calibration laboratories.\u201d During the audit, the management of external and internal documentation was reviewed, including documentation regarding the qualifications of laboratory personnel. The control and recording of test conditions, as well as compliance with procedures for the registration, handling, and storage of test items, were verified. No nonconformities were identified during the audit.<\/p>\n\n\n\n
Based on the results of the audits, the Institute\u2019s laboratory, as always, confirmed that it has the necessary resources and equipment to conduct physicochemical, microbiological, and biological testing of medicinal products and dietary supplements.<\/p>\n\n\n\n
(date of publication on the website: 30.04.2026)<\/p>\n","protected":false},"excerpt":{"rendered":"
The State Research Laboratory for Drug Quality Control has been accredited The State Research Laboratory for Drug Quality Control at the State Institution \u00abMarzieiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine\u00bb has been certified by the State Service of Ukraine on Medicines and Medical Devices (certificate of certification No. … Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7211,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ep_exclude_from_search":false,"footnotes":""},"class_list":["post-8088","page","type-page","status-publish"],"yoast_head":"\nThe State Research Laboratory for Drug Quality Control has been accredited (date of publication on the website: 30.04.2026) - State Institution \u00abMarzieiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine\u00bb<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/health.gov.ua\/en\/events\/main-events-of-the-institute-2026\/30-04-2026-the-state-research-laboratory-for-drug-quality-control-has-been-accredited\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The State Research Laboratory for Drug Quality Control has been accredited (date of publication on the website: 30.04.2026) - State Institution \u00abMarzieiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine\u00bb\" \/>\n<meta property=\"og:description\" content=\"The State Research Laboratory for Drug Quality Control has been accredited The State Research Laboratory for Drug Quality Control at the State Institution \u00abMarzieiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine\u00bb has been certified by the State Service of Ukraine on Medicines and Medical Devices (certificate of certification No. ... 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