SOME ASPECTS OF QUALITY RISK MANAGEMENT FOR THE FENSPIRIDE HYDROCHLORIDE (0.08 G COATED TABLETS) PRODUCTION PROCESS AT THE PHARMACEUTICAL DEVELOPMENT STAGE

摘要

The urgency to satisfy pharmaceutical regulatory requirements, including drug quality risk management, prompted the application of risk assessment methodology during the pharmaceutical development (PD) stage of an actual drug production process to be studied. Risk assessment results for the industrial process in combination with information regarding risks to the final product that were obtained during the PD allowed an objective opinion about the influence of the product properties and process parameters on critical drug quality parameters during its mass production to be formulated.