Application Note: Applying QbD in Process and Impurity Control Strategy Development

Global regulatory authorities continue to push Quality-by-Design (QbD) on pharmaceutical groups and their supporting corporate informatics infrastructure.

Effective leveraging of QbD in risk mitigation requires informatics platform innovation; particularly to support reduction of data abstraction, data assembly, and human data preparation.

Informatics software for Impurity control should optimally provide users with the ability to construct 'process maps'. The platform should also allow the user to visualize the wide variety of related spectroscopic and chromatographic data in a single environment for each stage and substance for efficient and informed decision-making.

Here we provide an overview of a new software application (Luminata™) developed specifically to address these platform innovation needs.

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