Analysis of risk factors of contamination by mechanical inclusions of laboratory series of the preparation “Niavit, solution for injections” at the pharmaceutical development stage
DOI:
https://doi.org/10.24959/uekj.19.27Keywords:
particulate matter, evaluations of risks, Ishikawa diagram, control, particles, solution for injections, NiavitAbstract
Aim. Using the Ishikawa diagram, one of the risk management tools, to examine potential risk factors on the stage of pharmaceutical development (PD), that affect the quality of the injectable medicinal preparation (MP) Niavit on an index the “Mechanical inclusions” (MI) and to further use of this information for making evaluation of MP for injections risks.
Materials and methods. Methodology is in-process applied causally and inquisitional analysis. For the exposure of potential factors that give the most considerable influence on quality of MP “Niavit, solution for injections” on an index “PM”, the Ishikawa diagram – graphic image of reasons and consequences is built. To examine visible and invisible PM in preparation for injections controling methods were used according to USP.
Results. Realization of analysis allowed to systematize possible risk factors that influence on quality laboratory to the series of MP “Niavit, solution for injections” on an index “PМ” and can result in negative consequences.
Conclusions. On the stage of PD possible risks related to the critical index of quality “PM” of “Niavit, solution for injections in ampoules for 2 ml”. Control of the laboratory series of preparation, produced taking into account all possible risks, on an index “PM” was confirmed by their accordance to the requirements of USP.
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