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App Note: JDSU – Fit-for-Purpose MicroNIR Spectrometer

Posted: 23 December 2013 | | No comments yet

Miniature and cost-effective NIR spectrometers are starting to facilitate QbD adoption…

There has been a lot of emphasis in recent years by the FDA towards applying Quality by Design (QbD) principles in the development and the manufacture of pharmaceutical products. Implementing QbD methodologies leads to a greater understanding of the process and the product, enabled by the use of on-line, at-line, and in-line process analytical technology (PAT) tools. Those technologies allow for systematic and scientific process control strategies and real-time process feedback, as well as perpetual knowledge building of the process understanding. The benefits are therefore higher quality products, improved product consistency, reduced product development cost, reduced manufacturing cost, and faster regulatory approvals…

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