ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Hazard

Inherent pharmacologic and toxicologic properties of a substance that adversely affects health of people, environment, process or product.

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

Publication Date: 2010

Hazard

(DOD) A condition that is prerequisite to a mishap.

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

Hazard

(ICH Q9) The potential source of harm (ISO/IEC Guide 51).

Publication Source: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems

Publication Date: 2008

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