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The guidance document supporting process analytical technology (PAT) released by the US Food & Drug Administration department is part of a broader initiative on current Good Manufacturing Practices to be followed by the pharmaceutical industry. The agency says that the goal of the PAT, which involves on-line, in-line, or at-line measurements at critical processing points for feedback and quality control, is to design and develop processes that ensure quality products.

Byline: Friedman, Y. Z. Advancec process control (APC) requires skilled control engineers, and where such engineers are not available, even well-implemented APC applications quickly become ineffective. That much is known [...]