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3 articles tagged FDA.
A composite of practitioner conversations on FDA and EU inspections that put process analytical technology and chemometric models in scope. Inspectors read the lifecycle records, not the qualification protocols.
Twenty years after the first FDA continuous manufacturing approval, the technology is no longer experimental - but adoption is uneven, and the bottlenecks are now organizational, not technical.
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.