When applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH guidelines.
PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?
Enshrined in the concept of Quality by Design is the premise that optimized pharmaceutical manufacturing requires detailed understanding of products and processes. With this in mind, many benefits can be achieved by combining modern powder characterization techniques with real processing experience.