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

  • Authors: Gabidova A.1, Galynkin V.2,3
  • Affiliations:
    1. ФГУП «Московский эндокринный завод»
    2. Федеральное государственное бюджетное образовательное учреждение высшего образования Санкт-Петербургский государственный технологический институт (технический университет), Санкт-Петербург
    3. ООО «РОСБИО», Санкт-петербург
  • Issue: Vol 1, No 1 (2019)
  • Pages: 32-37
  • Section: Pharmaceutical Sciences
  • URL: https://journals.eco-vector.com/PharmForm/article/view/18552
  • DOI: https://doi.org/10.17816/phf18552
  • Retraction date: 27.02.2020
  • Retraction reasons description:

    The article «Risk Analysis in the Production of Medicines” publishe in Pharmacy Formulas 1(1) 2019 by A. E. Gabidova and V.A. Galynkin is a duplicate of the article «Unified and simplified technological scheme in the production of the active pharmaceutical substances and finished pharmaceutical products» published in the Bulletin of the Saint Petersburg State Institute of Technology (Technical University). 2016; 36: 93-98. That was the reason for retraction.
    Revealed February 20, 2020 by the Editorial Board

  • Cite item


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

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

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

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

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

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


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Abstract: 349

PDF (Russian): 1794


CrossRef: 1

  1. Li N, Kalenik T. Safety Assessment of Aqueous and Supercritical CO2 Extracts of the Chaga Mushroom Inonotus obliguus. Food Processing: Techniques and Technology. 2021;51(1):125. doi: 10.21603/2074-9414-2021-1-125-133


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