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EMEA Clarifies Ambiguities in Genotoxicity Guideline

This article was originally published in The Gold Sheet

Executive Summary

EMEA explains genotoxic standard that was cited in Roche's Viracept recall

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Pharmaceutical Industry and FDA Preparing for ICH M7 Implementation

The pharmaceutical industry is concerned about the cost involved in setting up complex computational systems required for evaluating potential genotoxic impurities in drug substances and drug products under ICH M7. The guidance goes into effect in January 2016 for drugs in clinical development and in July 2017 for new and generic drug applications as well as drugs with post-approval changes.

Roche Builds Quality Risk Management Program in Response to Viracept Crisis

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.

Roche Builds Quality Risk Management Program in Response to Viracept Crisis

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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