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

Abstract

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.