Tag
8 articles tagged validation.
RMSEC, RMSECV, and RMSEP are all reported in units of the property being predicted. They mean three different things, and confusing them is how process labs quietly overpromise model accuracy.
Synthesised observations from PAT-adjacent engagements where data scientists from web-product backgrounds collide with chemometricians steeped in PLS, ASTM E1655, and calibration transfer.
A structured approach to RFP evaluation for inline process analyzers, covering specification verification, calibration transfer, validation evidence, FAT/SAT scope, and lifecycle maintenance burden.
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.
A partial least squares model rarely survives the move to a second instrument unchanged. A working protocol covers transfer set design, the standardisation method, and the acceptance criteria.
Six recent peer-reviewed PAT papers worth a read: lean chemometrics for spectroscopic models, simpler bioprocess Raman regressions, at-line terahertz for crystallinity, and PAT-with-machine-learning past the bioreactor.
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.
A user requirement specification is the contract between the process owner and everyone else. Done well it shrinks the project; done badly it bloats it. The structure that survives audit and procurement.