Planning a multi-site chemometric model rollout
A multi-site rollout is not one deployment repeated N times. Five upstream decisions - governance, transfer, validation, change control, data flow - determine whether site N behaves like site one.
Articles by Marcus Whitfield
FDA Quality Metrics program: what it means for analytical procedure data
The FDA's push to collect analytical laboratory quality metrics from drug manufacturers has taken a decade to become the voluntary QMM assessment. What laboratories should expect from the 2026 cycle.
Field notes: regulatory inspectors and PAT
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.
Field notes: validation engineers and the PAT lifecycle
A composite of conversations with validation engineers working on pharmaceutical and biopharmaceutical PAT installations. The hardest parts of the job sit at the seams between project, quality, and operations.
FDA emerging-tech pathway updates: AMT guidance final, ETP refresh due end-2026
FDA finalized the Advanced Manufacturing Technologies designation program in January 2025. The older Emerging Technology Program handles earlier engagement; its guidance refresh is due by end-2026 under PDUFA VII.
Continuous manufacturing in pharma: a status report through early 2026
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.
Field notes: what scaling PAT across multiple plants actually involves
A composite of conversations with engineers running multi-site PAT programs. The technical work is straightforward; the parts that go wrong are organizational, contractual, and cultural.
Field notes: pharma and chemicals run PAT in different cultures
A composite of observations from practitioners who have worked PAT projects on both pharmaceutical and bulk-chemicals sites. The instrument is often the same; almost everything around it is different.