In which phases is the quality risk management process divided?

21.09.2020

Question of the Week

Quality risk management is understood as a systematic and continuous process that allows the assessment, management and control of product quality risks throughout the entire product life cycle.
The process model presented in ICH Q9 comprises 5 stages:
● Initiating the process
● Risk assessment
● Risk management
● Risk communication
● Risk monitoring

[GMP Compliance Adviser, Chapter 19.B]

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