Quality by Design (QbD)

Ensuring Product Quality with Process Raman and FT-IR Spectroscopy

May 01, 2016


John Wasylyk, a principal scientist at Bristol-Myers Squibb in New York, New York, has been using quality by design (QbD), Raman spectroscopy, and Fourier transform infrared (FT-IR) spectroscopy in process development as well as for at-line and on-line monitoring of active pharmaceutical ingredient (API) crystallization. Here, he discusses the advantages, limitations, and challenges of these techniques.