The substantiation of scientific and methodical approaches to identification and evaluation of risks in parenteral medical forms combined production

Abstract

The article analyzes the scientific approaches to the assessment and minimization of the risks of cross contamination in the conditions of combined production, proposed an algorithm for the preliminary assessment of the risks of combined production of parenteral medical forms, developed an algorithm for a formalized assessment of the risks of cross contamination, the expert method substantiated the critical stages, the most significant factors and sources of risks of cross contamination of combined production of parenteral medical forms.Aim. To identify the factors and sources of risk of co-production of parenteral medical forms, to develop algorithms for assessing the risks of joint production of parenteral medical forms and formalized assessment of the risks of cross contamination.Materials and methods. Great attention was paid to preliminary assessment of the risks in combined production of parenteral medical forms; algorithm for a formalized assessment of the risks of cross contamination was taken into account; the expert method substantiated the critical stages.Results. Eleven stages of assessing the risks of combined production of parenteral drugs, four critical stages, three most significant factors and four most significant sources of risk of cross contamination were identified.Conclusions. The identified critical stages, factors, and sources of risk of cross contamination make it possible to identify benchmarks for assessing the risk of contamination of the combined production of parenteral medical forms.