ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Physical injury or damage to the health of people, or damage to property or the environment.

Publication Source: GAMP® Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures

Publication Date: 2005


(ICH Q9) Damage to health, including the damage that can occur from loss of product quality or availability.

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

Publication Date: 2008

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