Некоторые аспекты управления рисками для качества процессов производства лекарственного средства "Фенспирида гидрохлорид, таблетки покрытые оболочкой, 0,08 Г" на этапе фармацевтической разработке

Abstract

For the fulfillment of normative requirements in the pharmaceutical industry, including realization of the quality risk management for drug production, we have studied the stage of drug development for the production of a particular medicine based on application of the risk assessment methodology. Results of the assessment of risks inherent in technological process in combination with the information on risks for the final product (obtained during drug development) allow one to form objective notions about the influence of product properties and process parameters on the critical parameters of drug quality during its large-scale production.