Abstract

CUEVA MESTANZA, Ruben. Application of process analytical technology (PAT) to control critical quality attributes using NIR spectroscopy in a powder manufacturing process for suspension . Rev. Soc. Quím. Perú [online]. 2018, vol.84, n.4, pp.451-464. ISSN 1810-634X.

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).

Keywords : Quality control; critical quality attributes; NIR spectroscopy; Process Analytical Technology (PAT).

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )