From PAT to ICH Q14: how regulators harmonized process analytics vocabulary
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.
Articles by Dr. Friederike Hentschel
Chemometrics 101: the math that turns spectra into decisions
Spectra are not answers. The bridge between a 1,000-channel spectrum and a number you can act on is chemometrics — a small toolbox of multivariate methods, used the same way for forty years.
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.