We will discuss some of the spectroscopic tools (UV-Vis, FTIR, NIR, Raman, headspace mass spectroscopy) that can be used to gain better insight into processes. Application of PAT early in the development process provides insights that aid in identifying critical quality attributes and process parameters, and provide a measure of process variability. Examples of how use of PAT has contributed to increased process understanding will be provided. Beyond providing process understanding, one can apply PAT to ensure real-time assurance of products and processes by implementing PAT tools on production scale.
Beyond the systematic scientific understanding that underlies the application of PAT, implementation on scale entails a multidisciplinary team to ensure success and bring value to the process. We will discuss key aspects of PAT implementation in industry for assuring product quality during the manufacturing process.