Article | REF: PHA3050 V1

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

Already subscribed? Log in!

Automatically translated using artificial intelligence technology (Note that only the original version is binding) > find out more.

A | A

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...

You do not have access to this resource.

Exclusive to subscribers. 97% yet to be discovered!

Already subscribed? Log in!

The Ultimate Scientific and Technical Reference

A Comprehensive Knowledge Base, with over 1,200 authors and 100 scientific advisors

+ More than 10,000 articles and 1,000 how-to sheets, over 800 new or updated articles every year

From design to prototyping, right through to industrialization, the reference for securing the development of your industrial projects

This article is included in

Drugs and pharmaceuticals

This offer includes: