ICH Q9 Quality risk management

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/ICH/24235/2006
Published01/01/2006
Effective from01/01/2006
KeywordsRisk assessment, quality risk management, risk, harm, hazard, failure mode and effects analysis (FMEA)
DescriptionThis 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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