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Quality by Design Working Group (API)

The API Leadership Group recently formed a Quality-by-Design (QbD) Working Group to share industry experience with QbD and further develop our practices in this evolving field. The QbD group is exploring the following topics:

• Presentation of risk assessments in a filing and best practice for relating criticality to commitment (including best practice for ensuring appropriate quantitative risk assessment when building on an early qualitative assessment).
• Definition of critical process controls (parameter ranges, IPC’s etc) to minimize risk of difference in acceptability across regions.
• Verification of design space and bridging of scale.

The API QbD Working Group are currently focussed on developing a set of case histories to exemplify the verification of a design space on scale and respond to a recent FDA/EMA Q&A paper on that topic.