Quality by design–based development of vibrational spectroscopy methods

Abstract Vibrational spectroscopy that includes infrared, Fourier transformer infrared, and Raman spectroscopy founded as the key analytical technique within the process analytical tool toolbox and there are many examples available for conventional pharmaceutical laboratory and manufacturing functions. The drug development with the approach of quality by design is a systematic process that extended the analytical methods as defined by the International Conference on Harmonization (ICH). The development of a new analytical technique requires a control strategy that can manage risk and make sure that the method works as desired when validated and deployed. An analytical measurement that covers raw material chemical and physical properties to intermediate granule density measurements to imaging analysis of final products can be combined using multivariate approaches to model the design space for a pharmaceutical process.