By David Husman

Published in: IVT Jr GXP Compliance Vol 22 Issue 5

Published on: January 23, 2018

Abstract: Deviations occur across the pharmaceutical and device industries nearly every day. Companies have spent hundreds of hours and thousands of dollars to investigate deviations, identify their causes and implement corrective actions to prevent their recurrence. Yet with all of the investment we continue to frustrate both our personnel and our management as the same problems continue to recur.

FDA and other regulators routinely request to see lists of deviations, non-conformances, CAPAs, complaints, and out of specification investigations during inspections. For nearly 20 years, failure in these systems has been in the top 5 of all observations issued. So what are we doing wrong? This article attempts to explore the issues and provide some possible solutions and paths forward to eliminate the problems routinely documented as deviations within our manufacturing and testing environments. Although the examples focus on U.S. FDA, the problems and solutions are applicable worldwide.

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