The Department for Pharmacopoeial Reference Standards and Pharmacopoeial Research fulfils the functions prescribed by Order of the Ministry of Health of the Russian Federation No. 202 of 20 March 2020 “On the Metrological Service of the Ministry of Health of the Russian Federation as applied to medicinal products for human use”.
Main activities of the Pharmacopoeial Reference Standards and Pharmacopoeial Research Department
- Maintenance of the Register of reference standards of the Russian Pharmacopoeia,
- Creation and maintenance of the Collection of reference standards of the Russian Pharmacopoeia,
- Provision of stakeholders in the pharmaceutical market with pharmacopoeial reference standards.
Main objectives of the Pharmacopoeial Reference Standards and Pharmacopoeial Research Department
- Analysis, forecasting, and identification of the needs for pharmacopoeial reference standards.
- Organisation of pharmacopoeial reference standards certification and distribution.
- Creation and maintenance of the Register and Collection of reference standards of the Russian Pharmacopoeia.
- Provision of stakeholders in the pharmaceutical market and other legal entities with pharmacopoeial reference standards.
- Scientific and methodological support of interlaboratory comparative studies using pharmacopoeial reference standards.
- Organisation of practical evaluation of requirements included in general chapters/monographs and individual monographs to be included in the State Pharmacopoeia of the Russian Federation.
- Participation in the development of recommendations, guidelines, and other materials on medicinal product standardisation and quality control.
The Department works together with federal agencies in accordance with Decree of the Government of the Russian Federation No. 208 of 18 February 2022 (last updated on 14 April 2022) “On the provision of federal subsidies to the autonomous non-profit organisation ‘Agency for Technological Development’ to support projects involving the development of design documentation for components needed for industries” in ensuring the uniformity of measurements (Ministry of Industry and Trade of Russia). Together with the Agency for Technological Development, the Department contributes to the development of reference standards for quality control of medicines included in the Vital and Essential Medicines list.
The Department distributes pharmacopoeial reference standards at the regional and international levels (requests for pharmacopoeial reference standards come from all over Russia—from Kaliningrad to Siberia), and has close ties with pharmaceutical manufacturers of the Republic of Belarus.
Operational structure of the Pharmacopoeial Reference Standards and Pharmacopoeial Research Department
Methodological Support Division
Division Overview
The Division’s objective is to organise and provide methodological support to the certification of pharmacopoeial reference standards, and ensure provision of stakeholders in the pharmaceutical market with pharmacopoeial reference standards to be used in standardisation and quality control of medicines coming to or already available in the Russian market, at all stages of their life cycle.
Main activities of the Methodological Support Division
- Analysis of the needs for pharmacopoeial reference standards in the Russian pharmaceutical market.
- Handling of applications from manufacturers for certification of pharmacopoeial reference standards.
- Development of certification, verification, and validation procedures.
- Processing the results of candidate reference standard certification, preparation of certification documentation.
- Filling, packaging, labelling, and distribution of pharmacopoeial reference standards.
Analytical Division
Division Overview
The Division’s objectives are to perform certification of pharmacopoeial reference standards, validation and verification of test procedures, to develop new test procedures, contribute to scientific research performed by the Department.
The Analytical Division has modern high-tech equipment to carry out any types of tests needed for pharmacopoeial reference standard certification, as well as study by alternative methods.
For cooperation, please contact: fso@expmed.ru