ICH Q9 Provides Implementation Framework For Quality Risk Management
This article was originally published in The Pink Sheet Daily
Executive Summary
ICH's quality risk management draft guideline "Q9" provides a common language and systematic approach that will facilitate industry/regulator communications. ICH Q9 is intended to provide a practical toolbox to accompany the pharmaceutical development ("Q8") and newly agreed to quality systems ("Q10") facets of the ICH effort to evolve a more harmonized and flexible quality oversight process.