A single unit for laboratory testing of medicinal products, including medical immunobiological preparations, has been established at the State Expert Center of the Ministry of Health of Ukraine: the Pharmaceutical Analysis Laboratory.
The unit was formed by merging the Pharmaceutical Analysis Laboratory and the Laboratory for Quality Control of Medical Immunobiological Preparations.
The main goal is to ensure a unified approach to laboratory testing at the Center and to expand the scope, which will include chemical, physicochemical, microbiological, biological, virological and immunobiological testing methods, as well as expert work in the field of vaccine batch release.
The decision is intended to improve the organization and increase the efficiency of laboratory control of medicinal products at the State Expert Center of the Ministry of Health of Ukraine.
To date, the regulation of the new Pharmaceutical Analysis Laboratory has been developed and approved, with tasks and functions that fully cover all the previous functions and tasks performed by the Pharmaceutical Analysis Laboratory and the Laboratory for Quality Control of Medical Immunobiological Preparations.
Main functions and tasks of the updated Pharmaceutical Analysis Laboratory:
- carrying out, in the established procedure, laboratory testing of medicinal products, including medical immunobiological preparations, submitted for registration, in order to confirm the reproducibility of the quality control methods proposed by the applicant, upon referral by the Center;
- quality control or comparative studies of the antimicrobial activity of samples of finished medicinal products, including medical immunobiological preparations (and in bulk products), substances (active and excipient substances), and intermediate products used in the manufacture of medicinal products, and validation of quality control methods for medicinal products commissioned by legal entities and individuals;
- quality control of samples of medicinal products sent by the Center for clinical trials that will be registered in Ukraine;
- performing quality control of medicinal products, including medical immunobiological preparations, on referral from the State Service of Ukraine on Medicinal Products and Drugs Control or other state institutions and organizations;
- conducting interlaboratory (including arbitration) and state quality control of samples of medicinal products, including medical immunobiological preparations, on referral from authorized bodies;
- comparative studies of the antimicrobial activity of medicinal product samples;
- conducting tests to study and confirm the similarity of dissolution profiles of medicinal products;
- conducted on referral from the State Service of Ukraine on Medicines and Drugs Control:
- expert evaluation of the Summary Protocol of a vaccine batch (assessment of the manufacturer's batch release data);
- laboratory analysis of the vaccine at the manufacturer's site;
- issuing a vaccine batch release certificate based on the results of the expert evaluation of the Summary Protocol of the vaccine batch, the expert evaluation of the manufacturer's quality control materials for the batch of the medical immunobiological preparation (batch quality control protocols, analytical reports) and laboratory tests.
The Pharmaceutical Analysis Laboratory comprises eight structural units: the quality assurance department, the department of physicochemical methods, the department of chemical methods, the department of microbiological methods and antibiotic activity, the department of virological and immunobiological studies, the vivarium, the administrative department, and the department of logistics and technical support.
In its activities, the Pharmaceutical Analysis Laboratory will continue to be guided by the current legislation of Ukraine and the requirements of DSTU ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories,” ISO 9001 “Quality management systems. Requirements,” the recommendations “WHO Good Practices for Pharmaceutical Quality Control Laboratories” (WHO TRS, No. 957, 2010 – Annex 1), the provisions of Guideline ST-N MOZU 42-4.0:2020 “Medicinal products. Good manufacturing practice,” as amended, and other industry standards.
The creation of a unified laboratory complex is part of the strategy of the State Expert Center of the Ministry of Health of Ukraine aimed at improving the effectiveness of laboratory control and rationalizing the use of resources. This is in line with the goals of optimizing the activities of the State Expert Center of the Ministry of Health of Ukraine within the framework of the further creation of a single state control body and the European integration changes in the system of registration and quality control of medicinal products in Ukraine.
The Pharmaceutical Analysis Laboratory successfully passed an audit by the State Service of Ukraine on Medicinal Products and Drugs Control and was accredited for the right to conduct quality and safety control of medicinal products, including medical immunobiological preparations, in accordance with the scope of accreditation (ACCREDITATION CERTIFICATE No. 576 of 17.07.2024).
Within a month of the merger, the procedure for interaction with applicants will be updated. All necessary information will be posted on the official website in the section “Laboratory Control. Pharmaceutical Analysis Laboratory”.
Scope of attestation (to Certificate No. 576 of 17 July 2024)
