ICH Q9 Quality risk management

Table of contents

This document provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products.

Keywords: Risk assessment, quality risk management, risk, harm, hazard, failure mode and effects analysis (FMEA)

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