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Achieving Process Understanding: The Foundation of a Strategic PAT Program

By Ray Schneider, Chief Consulting Officer and Vice President, Tunnell Consulting Imagine a group of pharmaceutical manufacturing experts who convene to discuss the FDA’s Process Analytical Technology (PAT) initiative and over the course of two days never once delve into near infrared spectroscopy (NIR) — or virtually any other on-line technology. That’s exactly what happened at a recent PAT symposium comprising pharmaceutical executives, industry consultants, academics, and one of the initial leaders of the FDA’s PAT effort, Ajaz Hussain. Far from being a glaring omission, however, the relative absence of such discussion provided a striking confirmation of the real opportunity that PAT offers pharmaceutical companies: a chance to achieve systematic improvement in manufacturability through application of
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By Ray Schneider, Chief Consulting Officer and Vice President, Tunnell Consulting Imagine a group of pharmaceutical manufacturing experts who convene to discuss the FDA’s Process Analytical...

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