USP’s Global Efforts to Strengthen Standards and Accelerate Innovation for Biologics Include ICH Engagement

Direct engagement in the ICH guideline development and revision process is helping USP prioritize its related compendial standard setting, revision, and harmonization efforts, and, in turn, enriching ICH awareness of the pharmacopeial standards and approaches that can help inform its guidelines.

This symbiotic relationship is manifesting itself in the ICH guideline discussions USP is now involved with around: ● the analytical procedure lifecycle in revising Q2 (validation) and writing Q14 (development) ● impurities in revising Q3D (elemental impurities) and developing Q3E (extractables and leachables) ● viral safety evaluation in revising Q5A, and ● continuous manufacturing in developing Q13.

In addressing the evolution of USP’s role and current initiatives in the biologics arena at the 2020 PDA Europe annual meeting, held virtually in June, USP Global Biologics Senior Scientific Fellow Maura Kibbey highlighted the impact of USP’s engagement in the ICH development process. 

Also presenting at the session was European Pharmacopoeia (Ph. Eur.) Department Head Cathie Vielle, who serves as Secretary to the European Directorate for the Quality of Medicines (EDQM) Ph. Eur. Commission. Vielle explained the Ph. Eur. role in the European regulatory system and public health. Her talk encompassed Ph. Eur. standard setting for biologics and the implementation of the ICH impurity guidelines. [Editor’s Note: Vielle’s presentation will be reviewed in an IPQ story to follow.]

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