Quality by Design (QbD): the PAT framework's parent
QbD is the broader regulatory philosophy that PAT serves. A primer on the ICH and FDA documents that built it, the vocabulary it introduced, and how process analytics fits inside it.
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QbD is the broader regulatory philosophy that PAT serves. A primer on the ICH and FDA documents that built it, the vocabulary it introduced, and how process analytics fits inside it.
Twenty years of guidance documents - 2004 FDA PAT guidance, ICH Q8 through Q14, ASTM E2363 - turned a fragmented vocabulary into a working framework. A reading guide.