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.

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