Stephen Hammond, Mark Smith, Pfizer Global Supply, Peapack NJ, USA
The use of spectroscopic techniques such as NIR spectroscopy to deliver greater process understanding, either providing difficult to obtain compositional data or more data across a process has been a key factor in the expansion of QbD. The potential for condition monitoring of a unit operation in real-time during the manufacturing process adds enormously to the ability to understand, and reduce the risk of any unit operation.
This talk will describe the spectroscopic techniques used to assess the process during qualification, and the measurements applied to develop a RtR filing for a low dose product. The RTR approach has been approved in Europe and by FDA. Also in many other countries around the world.
The future state of QbD will be proposed, where modeling and control based on optimum process trajectories can be effective in reducing variation due to ingredients or processing equipment, that effects the economics of producing product.
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