The State Research Laboratory for Drug Quality Control has been accredited

The State Research Laboratory for Drug Quality Control at the State Institution «Marzieiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine» 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 “General Requirements for the Competence of Testing and Calibration Laboratories,” and the laboratory’s 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.

As of March 4, 2025, the Institute’s 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.

Audits are conducted regularly at the laboratory; in April, two external audits were conducted at the Institute’s laboratory by clients, namely JSC “Farmak,” Ukraine, and LLC “Istpharm,” Ukraine, in accordance with quality agreements.

On April 7, authorized specialists from JSC “Farmak” 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’s 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’s 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’s laboratory was recommended for inclusion in the list of contract laboratories of JSC “Farmak.”

On April 17, an audit was conducted at Istpharm LLC, Ukraine, to assess the compliance of contract laboratories’ 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 “General requirements for the competence of testing and calibration laboratories.” 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.

Based on the results of the audits, the Institute’s 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.

(date of publication on the website: 30.04.2026)