Process Analytical Technology (PAT) and Data Management Systems to Control Product Quality

EVENT: Interphex 2010              LOCATION: New York, NY, Javits Convention Center DATE: April 20 to 22, 2010 PRESENTER: Sebastien Branchu, Principle Pharmaceutical Scientist II, Manufacturing Science & Technology (MS&T), Abbott Ludwigshafen, Germany ABSTRACT:  Process Analytical Technology (PAT) and Data Management Systems to control product quality.

Process Analytical Technology (PAT) has been defined by the FDA as a system for designing, analyzing and controlling pharmaceutical manufacturing processes through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of assuring final product quality. A broad understanding of CPPs and accordingly monitoring and controlling them in a timely manner (preferably in-line or on-line) can be accomplished with PAT. The benefits are a reduction in over-processing, enhanced process and product consistency and minimization of rejects. Fully leveraging PAT benefits requires the use of Multivariate Data Analysis (MVDA) and Design of Experiments (DoE). This is because data analysis is key to developing process understanding and multivariate statistical process control.

The case study will describe the strategy and development of PAT sensors such as NIR at several process steps for a melt extrusion solid product. It will also explain how the data can be captured by management systems and analyzed with statistical tools to control and ensure product quality.