Quality risk management for manufacturing of pharmaceutical products - Concept and regulations : Risks and hazards: definitions and basic concepts

Risks and hazards: definitions and basic concepts
Quality risk management for manufacturing of pharmaceutical products - Concept and regulations

Authors : Mélisande BERNARD, Hassane SADOU YAYE, Jean-Jacques HOURI, Bernard DO

Publication date: December 10, 2015 | Lire en français

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1. Risks and hazards: definitions and basic concepts

The notion of risk, commonly used in everyday life, is complex and evolves over time. It takes on different meanings in different fields and specialties. Nevertheless, it is always associated with the notions of probability, damage, undesirable and/or dreaded events, and severity.

According to ISO 31000:2009 and the associated Guide 73 , risk is defined as the effect of uncertainty on the achievement of objectives, thus coupling...

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Risks and hazards: definitions and basic concepts