TC BMPQC structure
The Testing Centre for Biological Medicinal Products Quality Control was established in 2011.
The TC BMPQC employs 5 post-doctoral degree holders, 1 Professor, and 43 PhD graduates, all of whom have extensive experience in biological products evaluation and quality control.
The TC BMPQC includes 10 dedicated laboratories for different classes of biological medicinal products, and a vivarium:
- Laboratory for Organisation of BMP Testing
- Bacterial Vaccines Laboratory
- Viral Vaccines Laboratory
- Laboratory of Bacteriophages and Probiotics, with the Collection of Microorganisms
- Immunology Laboratory
- Laboratory of Immunoglobulins and Blood Products
- Laboratory of Anatoxins and Antitoxin Products
- Laboratory of Bacterial Culture Media and Cell Cultures
- BMP Biochemistry Laboratory
- Laboratory of Molecular Biology and Genetic Test Methods
- Vivarium
The laboratories have an extensive inventory of modern equipment and measuring instruments, make use of easily available up-to-date standards and regulations, and employ competent staff with extensive expertise in BMP quality control and dossier evaluation.
Main functions:
The Testing Centre performs the following functions:
– quality control of medicinal products, as requested by the Ministry of Health of the Russian Federation, in the context of the marketing authorisation procedure;
– batch release testing of immunobiological medicinal products to confirm their compliance with the established specifications, preparation of test protocols and conclusions on the batch/lot compliance with the authorised specifications and submission of these documents to the Federal Service for Surveillance in Healthcare (Roszdravnadzor);
– expert assistance in the form of medicinal product testing to control compliance of quality characteristics with the established specifications;
– development, certification, and re-certification of pharmacopoeial reference standards;
– distribution of Hazard Group (HG) 3 and 4 test strains.
The TC BMPQC is responsible for stocking, maintaining, and use of the National Collection of Pathogenic Microorganisms (NCPM), which includes over 5000 strains with over 500 strains used in the production and quality control of medicinal products, medical devices, and products for diagnosis, prevention, and treatment of infectious diseases.
The NCMP is used as a depository of patent-protected strains of all types of HG 3 and 4 bacteria for the purposes of the patent procedure.
The Viral Vaccines Laboratory incorporates the Anti-Rabies Centre as a functional unit.
Main objectives:
- BMP testing for compliance with the established specifications—as part of the marketing authorisation procedure (as requested by the Ministry of Health of the Russian Federation) and batch release;
- preparation and issuance of test protocols and conclusions on product compliance with the established specifications;
- expert assistance in the form of medicinal product testing to control compliance of quality characteristics with the established specifications;
- ensuring the reliability, impartiality, and the required level of accuracy of test results;
- technical maintenance of the equipment and measuring instruments used;
- handling of all complaints related to test results;
- introduction and implementation of modern BMP testing methods;
- regular review and updating of regulations, guidelines, QMS documentation, standard operating procedures, and other documents;
- ensuring compliance with the evaluation deadlines;
- evaluation of the immune response in individuals who received anti-rabies treatment;
- development, certification, and metrological evaluation of pharmacopoeial reference standards calibrated against international reference standards.
The TC BMPQC activities are governed by the following laws and regulations:
– Federal Law No. 61-FZ of 12 April 2010 ‘On Circulation of Medicines’, as amended,
– ‘Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use’ adopted by Decision of the Eurasian Economic Commission Council No. 78 of 3 November 2016, as amended,
– Federal Law No. 449-FZ of 28 November 2018 ‘On Amendments to Certain Legislative Acts of the Russian Federation Concerning Batch Release of Medicinal Products for Human Use’, as amended, etc.
Licenses
The TC BMPQC has accreditation in technical competence and impartiality in accordance with GOST ISO/IEC 17025-2019. Accreditation certificate No. RA.RU.21FL32 issued by the Federal Accreditation Service.
The TC BMPQC has the following licenses:
- to work with HG 2 and 4 human and animal pathogens and genetically modified organisms that must be handled in closed systems. License number 77.99.18.001.L.000051.04.08 of 21 April 2008;
- to distribute narcotic drugs, psychotropic substances and their precursors, to cultivate drug-contained crops. License number LО-77-03-000891 of 4 September 2019;
- medical license No. FS-77-01-007112 of 12 February 2014.