Benefits of ICH Q10 Touted by Pharma Quality Expert

April 11, 2024

Many drug developers could improve the alignment of their quality units and their business units — and potentially avoid Form 483 inspection observations — if they dusted off and applied the International Council on Harmonization’s ICH Q10 Pharmaceutical Quality System guidance, according to one pharma quality expert.

“When a quality unit and business unit are out of sync, the outcome is dysfunction, inefficiency and FDA 483s, or worse,” explained Tim Fischer, managing partner of Great Solutions, in a recent webinar hosted by FDAnews, a WCG company.

The FDA adopted the ICH Q10 guidance in 2009, endorsing it as a model for the relationship between the quality and business units. Although voluntary, the principles of ICH Q10 are showing up in 483 inspection observations. “If you see a 483 that says the quality unit is deficient and is not supported by senior management, you’ve got some serious trouble with that company,” Fischer said, in the webinar titled ICH Q10 Pharmaceutical Quality System—Unpacked and Refreshed.

Access the full webinar ICH Q10 Pharmaceutical Quality System—Unpacked and Refreshed here.

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