PAT within the QbD Framework: Real-Time End Point Detection for Powder Blends in a Compliant Environment
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A process analytical technology (PAT) method using a near infrared (NIR) spectrometer attached to a drum blender was developed for real-time end-point detection for an extragranular blend.
Methods and theory
The method and corresponding documentation are part of the control strategy for a recently filed and approved pharmaceutical product, and the method is currently in place and in use for manufacturing of this pharmaceutical product at GlaxoSmithKline.
Results and discussion
The immediate benefits are a dramatic reduction in blend time as well as real-time verification of blend homogeneity for every batch. The development of the blending end-point method is presented and a set of fundamental requirements for developing any PAT method is proposed.
It is discussed how the reported PAT end-point method fits with the proposed PAT framework, and the validation aspects required to achieve a compliant method for use in drug product manufacturing are presented.
KeywordsQbD PAT Blend Chemometrics NIR Compliant
This paper was presented at IFPAC10. Colleagues from the validation and automation departments in GSK are acknowledged for their support.
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