ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Risk

(ICH Q9) Combination of the probability of occurrence of harm and the severity of that harm. (ISO/IEC Guide 51)

Publication Source: ISO/TC209 Working Groups at 2001-03-31 – Committee Draft ISO/CD 14644-6 “Cleanrooms and associated controlled environments” – Part 6: Terms and Definitions

Risk

(IEEE) A measure of the probability and severity of undesired effects. Often taken as the simple product of probability and consequence.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

Risk

The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk".

Publication Source: Committees on Human Research

See also: Minimal Risk

Risk

Likelihood of an identified harmful consequence as a function of exposure to a hazard.

Publication Source: ISPE Baseline® Guide, Vol. 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)

Publication Date: 2010

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