Process analytical technology efficiency

The FDA also introduces the concept of process analytical technology (PAT). PAT refers to systems that are used to analyze, monitor, and control manufacturing processes on a continuous basis. The quality attributes and specifications of raw materials, in-process intermediates, and processes are measured in real time and compared with predetermined parameters so that deviations can be rectified in a proactive nature to assure that the end products conform to the level of quality as expected. It is believed that a system based on PAT being implemented in a real-time manner would improve manufacturing efficiency and simultaneously retain or improve the product quality through these interactive measurements and controls. 

The use of Process Analytical Technology (PAT) to fully characterize and control the manufacturing process may enable the biotechnology industry in the not too distant future to produce these complex molecules as cheaply and efficiently as traditional small molecule drugs. 

The opportunities for this form of computer technology are increasing within the changing regnlatory environment, encouraging more innovative uses of technology found in other industries and the use of Process Analytical Technologies (PAT), which offer potential supply chain efficiencies. 

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... 

It is a continuous process, therefore very well suited for the application of process analytical technologies (PAT) within the context of the Quality by Design approach introduced by recent FDA guidelines [3,4], As a continuous process, it has a high reproducibility as well, being simpler and more cost-efficient than conventional formulation processes. 

Doherty, S. LaPack, M. David, P. etal., Integrated analytical technology Instrumental in achieving efficient pharmaceutical process development National ACS Meeting, October 2001, Chicago, IL. 

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