Pharmacy FormulasPharmacy Formulas2713-153X2713-1602NWI MBP EP1855210.17816/phf18552AbstractA unified and simplified flow diagram of the production of active pharmaceutical ingredients and the finished dosage formGabidovaAlfiya<p>PhD of Pharmaceutical Sciences, Head Department of Preclini-cal and Clinical Research</p>pharminnovate@gmail.comGalynkinValery<p>Doctor of Engineering Science, Professor, Department of Tech-nology of Microbiological Synthesis, Deputy executive director of company ”ROSBIO”;</p>7731254@mail.ruhttps://orcid.org/0000-0003-2890-897X121220191132370512201905122019Copyright © 2019, Gabidova A., Galynkin V.2019<p>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.</p>Технологическая схемаунификацияжизненный циклмикробиологический рискфитопрепаратыфармацевтический рискуправление качествомаллергизацияGMPHAССP.[1. Габидова А.Э. Анализ микробиологического риска в производстве пищевых продуктов и лекарственных препаратов. Проспект науки. Санкт – Петербург. 2016. 384 с.][2. ГОСТ Р ИСО 22000 – 2007. Системы менеджмента безопасности пищевой продукции. Москва. Стандартинформ. 2007.][3. ГОСТ Р 52249 – 2009. Правила производства и контроля качества лекарственных препаратов. Москва. Стандартинформ. 2009.][4. Международный стандарт ISO 31000 – 2009. Риск Менеджмент – Принципы и руководства. Москва. Стандартинформ. 2009.][5. ГОСТ Р ЕН 2296 – 2009. Биотехнология. Оборудование. Методы контроля эффективности очистки. Москва. Стандартинформ. 2009.][6. Управление рисками качества (QRM) ICN.2006.][7. Емцев И.Т., Мишустин У.Н. Микробиология. М: Дрофа. 2006. 444 с.][8. Государственная Фармакопея XII. Москва. 2008. 425 с.][9. Риск – менеджмент. Технический риск. 2013.]