A PAT-based qualification of pharmaceutical excipients produced by batch or continuous processing – Abstract
Highlights
• Qualification of entire processes based on CQAs of the final product (excipient).
• Use of analytical methods (Raman, X-ray- and laser diffraction) with MVDA.
• The value of such combined strategy is to produce a better diagnostics of quality.
• Evidence-driven diagnostics of which process delivers a more consistent end-product.
• Strategy for a risk-based supplier qualification using an analytical data matrix.