Scientific journal
Scientific Review. Biological science
ISSN 2500-3399
ПИ №ФС77-57454

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OPTIMIZATION OF MONITORING SYSTEM OF MEDICAL IMMUNOLOGICALS BIOTECHNOLOGY MANUFACTURING ISSUED BY FEDERAL GOVERNMENT HEALTH INSTITUTION «STAVROPOL PLAGUE CONTROL RESEARCH INSTITUTE» OF THE ROSPOTREBNADZOR

Tyumentseva I.S. 1 Afanasiev E.N. 1 Kurcheva S.A. 1 Garkusha Y.Y. 1 Semircheva A.A. 1 Startseva O.L. 1 Zhdanova E.V. 1
1 FGHI Stavropol plague control institute of the Rospotrebnadzor
The article describes the current requirements for the organization of production of diagnostic products and a systematic approach to products quality management. The analysis of biotechnological processes in the production of a variety of medical immunobiological preparations (MIP) issued by FEDERAL STATE INSTITUTION OF PUBLIC HEALTY “STAVROPOL PLAGUE CONTROL RESEARCH INSTITUTE” OF THE ROSPOTREBNADZOR is conducted. The scheme of the production of MIP is provided and the system of quality control (critical control points of production are defined, as well as corrective measures in case of non-conforming product) is developed. The functioning of the presented system is possible only with the full cooperation of all its units at all stages of production and standardization of operating procedures. Such an integrated approach with the production of MIP series of various kinds, showed the effectiveness of the system and ensured the high quality of the final product while saving labor and material resources.