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In the present work are defined the steps to follow in order to determine the critical quality attributes in a manufacturing process of a pharmaceutical product. Analyzing the impact and criticality of each of the manufacturing operations in the quality of the product and defining the critical attributes to control. According to the results obtained, it was decided to apply NIR spectroscopy as an alternative to conventional methods to quickly control the critical attributes during the manufacturing process of a powder for suspension. The objective is to build the quality of the final product, controlling critical quality attributes of intermediate products in the same process by applying Process Analytical Technology (PAT).

revista de la sociedad química del perú/revista de la sociedad química del perú

APLICACIÓN DE TECNOLOGÍA ANALÍTICA DE PROCESO (PAT) PARA CONTROLAR ATRIBUTOS DE CALIDAD CRÍTICOS UTILIZANDO LA ESPECTROSCOPIA NIR EN UN PROCESO DE FABRICACIÓN DE UN POLVO PARA SUSPENSIÓN