Process analytical technology design space

The recent FDA initiative on Process Analytical Technology (PAT) attempts to define a design space for unit operations such as compaction... 

Process analytical technology (PAT) can be developed early in development with a line of sight to commercial process control (ICH Qll 2011a). Easily integrated into the process equipment, as shown in Fig. 7.1, the application of in-line probes can provide unique opportunities to monitor processes in line. Spectroscopic techniques such as ultraviolet/visible (UV/VIS), near-infrared (NIR), and Raman can be utilized in line at the extmder die to ensure critical quality attributes (CQAs) such as composition and amorphous conversion of the API. Validation of these techniques at the pilot scale and transfer to the commercial scale allow for efficient manufacture of commercial material in a continuous manner and the implementation of a process control strategy that enables material outside the design space to be diverted to waste... 

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