Manufacturers Lack Understanding of QRM, Despite New Guidance Says Expert

Only about half of drug manufacturers have systems that comply with what regulatory bodies want to see in Quality Risk Management (QRM) — though the FDA and the International Council for Harmonisation (ICH) both released updated guidance on the topic earlier this year, said Beth Slater, industry veteran and founder and president of consulting firm Quality Confidential.

And a key component of the new guidance, said Slater, is a big one: a mandate that manufacturers have the “ability to show metrics beyond counting” in measuring the efficiency and effectiveness of their Quality Management System (QMS) via risk management processes.

She explained that many manufacturers create metrics that measure the efficiency of their QMS without considering QRM outputs that would provide actual insights into effectiveness.

Learn more from Beth Slater at her upcoming presentation “The Intersection of Risk and Quality,” at the GMP Quality Management vSummit 2023 produced by FDAnews, a WCG company, Oct. 11-12.

Register for the GMP Quality Management vSummit here.

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