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This article was originally published in The Gold Sheet

Executive Summary

... draft guideline Q9 from ICH represents an important step forward down the industry/regulator communication pathway. By offering a common language and systematic approach, ICH Q9 is intended to provide a practical risk management toolbox to facilitate implementation of the pharmaceutical development (Q8) and quality systems (Q10) facets of the ICH effort to evolve a more harmonized and flexible quality oversight process. A recent PQRI workshop complements the ICH effort in exploring the usefulness of the various risk management tools. FDA, meanwhile, is continuing to refine its drug inspection program on risk-based lines through its site selection model and quality systems approach. An ongoing study of FDA data along with a review of recent high-profile enforcement actions show facility ownership changes and their impact on the functionality of the quality system are a non-compliance risk factor. Regulatory flexibility for industry will hinge on assuring that the quality organization has full corporate backing. [An FDA investigator-eye view of what a good organization looks like is included along with the terms of GlaxoSmithKline’s recent consent decree with FDA].

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