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September 15, 2008 (Vol. 28, No. 16)

FDA Backs PAT to Help Solve Manufacturing Woes

Process Analytical Technology Is a Key Part of Agency’s Plan for the 21st Century

  • Process analytical technology (PAT) has been the subject of regular discussion since the FDA released its guidance for the industry in September 2004. The goal, then and now, was to provide a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement and control of critical variables ...

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