03.22.22 -- ICH & USP <1220>: Implementing A QbD Analytical Framework

The International Council for Harmonization (ICH) and the United States Pharmacopoeia (USP) are finalizing draft guidelines that describe a new paradigm for analytical development based on the quality by design (QbD) approach used for pharmaceutical development. The new chapter will become official on May 1, 2022.

Pharma quality and compliance leaders must anticipate potential manufacturing issues before they happen by leveraging risk-based methodologies, continuously monitoring their systems, and tracking the profusion of data generated during the process. This article outlines the potential of data and analytics to improve quality performance — and how leaders can get their production team’s culture in step with this new normal.