Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product life cycle. Other models could be used. The emphasis on each component of the framework might differ from case to case but a robust process will incorporate consideration of all the elements at a level of detail that is commensurate with the specific risk.
Figure 1: Overview of a typical quality risk management process
[Source: Guidance for Industry Q9 Quality Risk Management
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
June 2006
ICH]
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