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GHTF guidance will tackle 'CAPA' acronym

This article was originally published in The Silver Sheet

Executive Summary

The Global Harmonization Task Force's (GHTF) long-awaited guidance document on corrective and preventive action (CAPA) should be ready in draft form by January, FDA GMP/quality systems expert Kim Trautman says ("The Silver Sheet" July 2009). The draft guidance will attempt to avoid using the word CAPA "because it's so misused," she says. The problem with the CAPA acronym is that "people think that you have to perform a preventive action for every corrective action," Trautman told "The Silver Sheet." "This is not true, and does not align with the definition of preventive action and corrective action in ISO 9000," she says. ISO 9000 is the overarching standard for quality management systems in all industries. "We still use ['CAPA'] in the document, but we discuss the problems with the acronym," Trautman notes

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