On January 5, 2024, the State Medical Service of NAMNU hosted a delegation of the State Medical Service of the Ministry of Health of Ukraine with the aim of familiarizing new employees of the service and management with the activities of a more modern laboratory of our state, which has been engaged in the control of medicinal products for more than 30 years in Ukraine.

Director of the institute Corresponding Member of the NAMSU, Doctor of Medical Sciences, Professor Prof. Nadiya Polka introduced the visitors to the long history and achievements of the SI "O.M. Marzieiev Institute for Public Health", and the head of the laboratory N. Ostanina familiarized the employees of the State Medical Service with all stages of the laboratory's activity.

Today, the laboratory employs 45 researchers, including 4 doctors of science (M. Levin, V. Brytsun, O. Surmasheva, M. Buzynny), more than 10 candidates of sciences, graduate students and research workers , who each have two higher educations. Even laboratory workers have higher education.

The laboratory is equipped with modern equipment for conducting product quality studies for compliance with Ukrainian, European, British, etc. Pharmacopoeia of the World.

The laboratory is engaged in scientific activities during the entire period of its existence, and this is helped by the fact that:

· the laboratory conducts quality control of dietary supplements as directed by authorized bodies;

· carries out control of drugs imported into the territory of Ukraine (as directed by the State Medical Service);

· carries out control of pharmaceuticals imported into the territory of Ukraine (as directed by the State Medical Service) verifies the reproducibility of quality control methods during registration (re-registration) of pharmaceuticals;

· deals with the development and validation of quality control methods, conducts studies of drug stability;

· carries out arbitration control, quality control of medical products, toys, cosmetics, dietary supplements, etc.;

· participates in the preparation of proposals for the development of projects of normative acts regarding the implementation of state quality control of drugs, dietary supplements, cosmetics, etc.

In 2014, as a result of the implementation of scientific topics and with the assistance of the pharmacopoeial center of the Ministry of Health, a separate section was created for the first time in Ukraine, which included the general article "Dietary supplements". This article is extremely important for Ukraine, as it allows, despite its advisory and informational nature, to formulate unified pharmacopoeial quality standards for a large number of biologically active objects.

In 2020, the State Pharmacopoeia of Ukraine 2.0 (Supplement 4) introduced an updated article "Dietary supplements", which was developed on the basis of the amended norms of the current legislation of Ukraine, taking into account the requirements of modern international legislation.

Natalya Ostanina familiarized the specialists of the State Medical Service with the quality management system implemented in the laboratory since accreditation (in 2004) at NAAU according to the international standard of DSTU EN ISO/IEC 17025:2019 (EN ISO/IEC 17025:2017, IDT; ISO/IEC 17025 :2017 IDT).

Today, it is the only laboratory that has accreditation according to this standard (among authorized DLS laboratories) and performs quality control of drugs. The laboratory is also certified according to the DSTU EN ISO 9001:2018 standard, certified by the State Medical Service of the Ministry of Health and supports WHO Prequalification since 2015.

The visitors were introduced to the work of the laboratory, from the beginning of the movement of samples to the issuance of the final certificate of analysis. The new equipment of the laboratory, namely ISR, HPLC, GC, IR, etc., aroused great interest. Laboratory specialists gave comprehensive answers to all visitors' questions.

The laboratory has a license to work in the quality control of drugs that belong to the list of narcotic drugs, psychotropic substances and precursors.

During the 30 years of its existence, the entire staff of the laboratory undergoes advanced training in all areas of activity, participates in international conferences, symposia and seminars with scientific reports, and also conducts an exchange of experience with well-known foreign laboratories, manufacturers of pharmaceutical products in Europe, Australia, Asia, America, China, India etc.

Employees of the laboratory in their activities develop patents, the results of scientific research are published in scientific Ukrainian and foreign publications.

We would like to emphasize that the laboratory did not stop its work even during the beginning of hostilities, it maintained a vivarium, which was absolutely necessary for quality control of injectables according to the indicators "Toxicity" and "Pirogenicity", especially in the first days of the invasion to ensure immediate need in drugs at this time.

The laboratory is equipped with an automatic system for maintaining and monitoring the temperature regime during the entire period of drug control and storage.

Experienced employees of the laboratory conduct training for students of the State Medical University named after Bogomolets, University named after Sikorsky, etc. higher institutions, conduct student internships and internships, conduct lecture-based educational activities.

The guests visited the laboratory's vivarium, the microbiological unit, got acquainted with the archives of pharmaceuticals and laboratory standards created according to European requirements and with regulatory documentation developed in the quality management system of our laboratory.

Our LIMS information system aroused great interest among visitors, and well-known administrators and developers of our LIMS V. Bryazkalo and A. Cheremenko provided necessary consultations on the organization of this laboratory system, its validation, etc.

Employees of the quality management system of the laboratory have familiarized themselves with information on a large number of conducted external and internal audits, which have practically no comments.

Upon completion, the director of the institute N. Polka thanked the deputy head of the State Medical Service V. Korolenko and all visitors for their interest in the laboratory, its employees, the activities it is engaged in, and expressed a desire to cooperate more closely with our scientists and to conduct more joint research for the benefit of our state.