ICH Guideline Q9 (R1) on Quality Risk Management

6 February 2023 – the EMA published step 5 of the ICH Q9 (R1) guideline on quality risk management.

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.

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