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October 01, 2008 (Vol. 28, No. 17)

FDA Pushes PAT and Companies Shove Back

Even with Perks, PAT Implementation Remains Stalled

  • Back in 2002 the FDA announced an initiative to shift regulation of drug manufacturing to a more process-centric validation approach, as opposed to the current product-centric one. Process analytical technology (PAT) was set up to optimize manufacturing and reduce resistance to the use of new production technologies. PAT ...

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