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Conduct CAPA Activities Appropriately, FDA Warns Manufacturers

This article was originally published in The Silver Sheet

Executive Summary

CORRECTIONS, CORRECTIVE ACTIONS AND PREVENTIVE ACTIONS are not being applied correctly by manufacturers, FDA says. "Corrections are spot fixes for a particular product or issue [and] are followed by corrective actions, which are more systemic," says FDA/GMP expert Kim Trautman. Further, she often sees "so many things called 'preventive actions' that aren't preventive actions." A Global Harmonization Task Force draft guidance on the topic may clear up industry confusion. It details a four-part approach that companies can use when launching a CAPA system, including identifying quality data sources, analyzing data, conducting investigations and keeping top management informed. Device firms Becton Dickinson (BD) and AGA Medical also explain how they apply risk management principles to determine whether product problems should be elevated to their CAPA systems

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