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.
Tag
#GMP
4 articles tagged GMP.
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.
Validating a chemometric model for GMP: a working checklist
ICH Q14 sets the framework. ASTM E1655 sets the practice. The intersection - what an inspector actually wants to see in a chemometric validation file - is a short, specific list.