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    FDA encourages industry to adopt modeling tools to ensure stable processes

    An official with the US Food and Drug Administration (FDA) encouraged the pharmaceutical industry to adopt advanced process control (APC) modeling tools to ensure that manufacturing processes are operating in a state of control, asserting that these processes are often reactively monitored rather than proactively controlled.   “Our process capabilities remain at two or three sigma, because we are relying on manufacturing of the last century,” said Stelios Tsinontides, ...