A Theoretical Framework for Real Time Release with NIR and Chemometrics

Abstract

The increasing use of NIR and process data acquisition systems in industry facilitates the realisation of real time release (RTR). RTR is a system of pharmaceutical product release that provides assurance of the intended product quality based on the information collected during the manufacturing process and on the compliance with specific GMP requirements.1 RTR is product and process specific. The development of a RTR system begins with risk assessment and involves the use of designed experiments to determine how important process parameters afect critical quality attributes of a final product. Through process understanding and control of process variability, consistent quality may be achieved, and the need for final quality tests reduced or eliminated. In this column the authors summarise their approach to using NIR for successful RTR.