REVIEW

Developing the system of state control of drug quality through formation of competence centers in federal laboratories of the Information Center for Expertise, Accounting and Analysis of Circulation of Human Medicinal Products of the Federal Supervisory Agency for Healthcare of Russia

Galeev RR1,2, Lileeva EG2, Ryzhkova EA1, Galeeva EV1,2, Lezhnina NA1,2
About authors

1 Information Center for Expertise, Accounting and Analysis of Circulation of Human Medicinal Products of the Federal Supervisory Agency for Healthcare, Moscow, Russia

2 Yaroslavl State Medical University, Yaroslavl, Russia

Correspondence should be addressed: Elena G. Lileeva
ul. Popova, 24, Yaroslavl, 150010, Russia; ur.xednay@6002aveelile

About paper

Author contribution: Galeev RR — article concept, study planning; Lileeva EG — literature selection and analysis; Ryzhkova EA — data generalization, text writing; Galeeva EV — data collection, data analysis; Lezhnina NA — data interpretation, preparing a draft of the manuscript.

Received: 2022-10-20 Accepted: 2022-11-25 Published online: 2023-02-01
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State control over the drug quality is a key component of the healthcare system aimed at provision of patients with safe and effective medicinal products [1]. Stable development of this direction was closely associated with update of testing laboratories, which performed the function, and was characterized as a stable growth of laboratory competencies in the field of not just implementation of new analytical methods, but also in the systemic approach to improvement of skills and knowledge of personnel directly involved in laboratory research. A common approach reflected in accreditation criteria for compliance with GOST ISO 17025 means that the testing laboratory has a plan for internal and external education. However, conventional attitude to this issue does not lead to the desired practical effect. Then the laboratory is urged to find additional ways of development. Formation of competence centers by a certain vector of knowledge on the basis of testing centers can be a perspective option of the systemic approach to updating skills of the personnel. The Yaroslavl branch of the Information Center for Expertise, Accounting and Analysis of Circulation of Human Medicinal Products of the Federal Supervisory Agency for Healthcare and basic department of innovative pharmacy of the Yaroslavl State Medical University that successfully uses the basis can serve as examples of such an approach.

Keywords: Raman spectroscopy, laboratory of the Federal Supervisory Agency for Healthcare, basic department of innovative pharmacy, HPLC, GLP

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