Process analytical technology quality control

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. 

A.S. El-Hagrasy, F.D Amico and J.K. Drennen III, A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part II Qualitiative near-infrared models for prediction of blend homogeneity, J. Pharm. ScL, 95(2), 407 21 (2006). 

A new program at FDA called process analytical technology (PAT) allows the use of continuous process control systems that measure and assess quality during the manufacturing process rather than between batches. The framework specifies the development of manufacturing processes that can consistently ensure a predefined quality at the end of the manufacturing run. Such procedures would be consistent with the basic tenet for quality by design inherent in currently available commercial control systems. 

Sukowski, L., and Ulmschneider, M. (2005), In-line process analytical technology on qualitative NIR modelhng An innovative approach for the pharmaceutical quality control, Pharmlnd, 67(7), 830-835. 

Commit to employing innovative quality control tools, such as process analytical technologies. 

Process Analytical Technology or conventional periodic production checks on quality, purity, contaminants, and safety controls... 

The current regulatory climate of QbD places an emphasis on clinically relevant specifications and methods for in vitro dissolution.20 Development scientists should identify dissolution methodology that has been closely examined for its relevance to in vivo performance, as well as for mechanistic information. In other words, the release mechanism of the product should be understood and the dissolution test should be able to detect changes reflecting deviation of the mechanism. There is also the quality control (QC) side of dissolution testing, which, until the process analytical technology (PAT) develops beyond the current capabilities, is very important for stability and end-product release testing. 

With the use of microprocess technology, the fluorination with DAST can be performed under decomposition conditions in continuous-flow mode [50], Temperatures of 90-100 °C and reaction times of 60-120 min are necessary for high conversions in order to compensate for the slow intrinsic reaction rate. A continuous quality control allows regulation of the process parameters (PAT, process analytical technology). A throughput of 5-10kg/day using three parallel modules was achieved. 

Keywords monitoring, quality control, process analytical technology, modelling... 

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