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Fit-for-Purpose MicroNIR Spectrometer Facilitates Quality-by-Design (QbD) Adoption

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Fit-for-Purpose MicroNIR Spectrometer Facilitates Quality-by-Design (QbD) Adoption

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In recent years, the FDA has emphasized applying QbD principles to the development and manufacture of pharmaceuticals. Implementing QbD methodologies along with on-line, at-line, and in-line process analytical technology (PAT) tools leads to a greater understanding of both the process and the product. This enhanced understanding enables systematic and scientific process-control strategies and real-time process feedback, as well as perpetual knowledge building of the process itself.

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