A unified and simplified flow diagram of the production of active pharmaceutical ingredients and the finished dosage form


The article shows that all biotechnological processes consist of four stages which include the step of obtaining the biomass (micro-organisms), fitosyrya biomass (plants, lichens) and biomass from animal raw materials; obtaining the active pharmaceutical substance; obtaining the final dosage form; storage and sale of APS and SFS. The authors have proposed a unified and simplified process sequence that represents the life cycle of the production of APS and SFR, showing the potential risks. Introduction of the HACCP system at the same time to the GMP system allows the identification of CCPs and therefore to analyze the product and manage the risk only in the CCP. The authors have proposed a multi-level model of a complex of pharmaceutical quality system. It is necessary to emphasize that in all environmental conditions to obtain drugs should be carried out in strict compliance with GMP and HACCP system and under the strict control of all types of risk, and, in particular, be sure to microbiological risk.

About the authors

Alfiya Gabidova

ФГУП «Московский эндокринный завод»

Author for correspondence.
Email: pharminnovate@gmail.com

Russian Federation, 109052, г. Москва, ул. Новохохловская, д. 25

PhD of Pharmaceutical Sciences, Head Department of Preclini-cal and Clinical Research

Valery Galynkin

Федеральное государственное бюджетное образовательное учреждение высшего образования Санкт-Петербургский государственный технологический институт (технический университет), Санкт-Петербург;
ООО «РОСБИО», Санкт-петербург

Email: 7731254@mail.ru
ORCID iD: 0000-0003-2890-897X

Russian Federation, 198013, Санкт-Петербург, пр. Московский, д. 26; 192019, г. САНКТ-ПЕТЕРБУРГ, ул. МЕЛЬНИЧНАЯ, 12 А

Doctor of Engineering Science, Professor, Department of Tech-nology of Microbiological Synthesis, Deputy executive director of company ”ROSBIO”;


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Abstract - 170

PDF (Russian) - 447


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