Main functions:
Quality control of medicinal products in accordance with the Federal Law No. 61-FZ ‘On Circulation of Medicines’ of 12 April 2010, as amended (hereinafter—FZ-61), and the Decision of the Eurasian Economic Commission Council No. 78 ‘On the Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use’ of 3 November 2016, as amended (hereinafter—Decision of the EEC Council).
Quality control of cell-based products (BCPs) in accordance with the Federal Law No. 180-FZ ‘On Cell-Based Products’ of 23 June 2016 (hereinafter—FZ-180).
Quality control testing of medicinal products in accordance with the Federal Law No. 449-FZ ‘On Amendments to Certain Legislative Acts of the Russian Federation Concerning Batch Release of Medicinal Products for Human Use’ of 28 November 2018 (hereinafter—FZ-449).
Main objectives:
Quality control of medicinal and cell-based products, as requested by the Ministry of Health of the Russian Federation, in accordance with FZ-61, Decision of the EEC Council, and FZ-180.
Batch release testing of medicinal products to confirm their compliance with the established specifications, according to FZ-449.
Ensuring the proper level of testing.
Maintenance and improvement of the FSBI ‘SCEEMP’s and the TC MPQC’s Quality Management Systems.
Laboratory testing of candidate pharmacopoeial reference standards.
Participation in the elaboration of pharmacopoeial monographs and general chapters, and experimental verification of the pharmacopoeial procedures, aimed at harmonisation of the Russian Pharmacopoeia requirements with those of the world leading pharmacopoeias.
Research in medicine quality evaluation and control.
Participation in the FSBI ‘SCEEMP’ education and training activities.
Contribution to the TC MPQC staff training.
Preparation for and participation in inspections of TC MPQC activities during licensing, accreditation, external and internal audits.
TC MPQC structure
The TC MPQC includes 13 laboratories.
Laboratory for Control and Coordination of Testing: organisational support for medicine quality control performed as part of the marketing authorisation procedure; preparation of titrants.
Laboratory of Chemical Pharmaceutical Products: quality control of chemical pharmaceutical products as part of the marketing authorisation procedure.
Laboratory of Chemical Pharmaceutical Substances: quality control of chemical pharmaceutical substances as part of the marketing authorisation procedure.
Laboratory of Vitamins, Hormones and their Synthetic Analogues: quality control of vitamins, hormones and their synthetic analogues as part of the marketing authorisation procedure.
Antibiotics Laboratory: quality control of antibiotics as part of the marketing authorisation procedure.
Laboratory of Herbal and Homeopathic Medicinal Products: quality control of herbal and homeopathic medicinal products as part of the marketing authorisation procedure.
Laboratory of Cell-Based Products: quality control of cell-based products as part of the marketing authorisation procedure.
Laboratory of Biotechnology-Derived Medicinal Products: quality control of biotechnology-derived medicinal products as part of the marketing authorisation procedure.
Laboratory of Radiopharmaceuticals and Reagent Kits: quality control of radiopharmaceuticals and in vitro diagnostics reagent kits as part of the marketing authorisation procedure.
Microbiology Laboratory: microbiological testing of medicinal products as part of the marketing authorisation procedure.
Laboratory of Gas-Liquid Chromatography: quality control of medicinal products by GLC as part of the marketing authorisation procedure.
Laboratory of Spectroscopic Methods: quality control of medicinal products by nuclear magnetic resonance spectroscopy, inductively coupled plasma-atomic emission spectrometry, inductively coupled plasma-mass spectrometry, atomic absorption spectrometry, X-ray powder diffraction.
Pharmacology Laboratory: quality control of biological properties of medicinal products as part of the marketing authorisation procedure.
Key accomplishments
The TC MPQC has accreditation in medicine quality control methods from the Federal Accreditation Service.
The TC MPQC is included in the List of the WHO Prequalified Quality Control Laboratories and was found compliant with the WHO GMP and ‘Good Practices for Pharmaceutical Quality Control Laboratories’.
The TC MPQC has an associate member status in the General European Network of Official Medicines Control Laboratories (GEON) of the European Directorate for the Quality of Medicines & Healthcare (EDQM) of the Council of Europe.
Other information
The TC MPQC has an extensive inventory of modern measuring instruments and equipment to perform almost any types of tests described in the Russian and world leading pharmacopoeias.
The tests are performed using appropriately calibrated and qualified measuring instruments and equipment.
The reagents and expendables used in medicine quality control comply with the requirements of the Russian and other (where applicable) pharmacopoeias. The choice of reagents and expendables is governed by the applicants’ specifications.
TC MPQC employees aim to improve their professional level by taking part in conferences, peer-learning seminars, and trainings by Russian and foreign educational providers.
The Testing Centre’s laboratories have taken part in Proficiency Testing Studies (PTSs) organised by EDQM (EC), NIFDC (PRC), BelGIM (Belarus). The obtained PTS certificates confirm proficiency of the Testing Centre’s laboratories in the following test methods: Optical rotation, Dissolution, Assay (HPLC, spectrophotometry, titrimetry), Impurities (HPLC), Melting point, Bacterial endotoxins, etc.