risk analyses
- Guideline or reference source
- ICHQ3D Guideline for elemental impurities
- ICHQ9 Quality Risk Management
- Definition
- The estimation of the risk associated with the identified hazards. It is the qualitative or quantitative process of linking the likelihood of occurrence and severity of harms. In some risk management tools, the ability to detect the harm (detectability) also factors in the estimation of risk.
- Related Term
- risk identification
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