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ICH Q9 Revision Delayed By Three Months Due To COVID; Focus Spans Risk Assessments, Shortages

 
• By Shannon Brown

Extension will add training materials with goal of reducing quality defects and recalls. Revision process will also address shortage indicators related to production failures in an attempt to head off drug shortages.

ICH Q9 revision update • Source: Alamy

The revision of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Q9 guideline, which covers Quality Risk Management, has been delayed by approximately three months due to COVID-19, but the process continues to move forward.

This will be “quite a targeted revision,” according to Kevin O'Donnell, a senior GMP inspector at Ireland’s Health Products Regulatory Authority. Speaking at the PDA/FDA Joint Regulatory Conference on 30 September, O’Donnell said, “There are many aspects of the guideline we will not be revising, and this is not a full rewrite by any means

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