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Roche Builds Quality Risk Management Program in Response to Viracept Crisis

This article was originally published in The Gold Sheet

Executive Summary

Roche's QRM program forged in crisis after Viracept recalled from AIDS epidemic in Africa due to GMP snafu. Upper management promised EU regulators a global review, called QuaSar. Massive effort involved training thousands of workers on how to assess risks and performing 100,000 FMEA risk assessments in just the first year. How Roche addressed the risks identified, replacing machines and even whole facilities when deemed necessary. How Roche transitioned to the proactive post-crisis second phase of its QRM program. The problem with doing FMEAs on Excel spreadsheets.

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