What are the individual steps of an efficient QRM process?

10.11.2025

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(R1) comprises 5 stages: Initiating a QRM process, Risk assessment, Risk control, Risk communication and Risk review.

[GMP Compliance Adviser, Chapter 19.C]

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24.11.2025

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How is a QRM process initiated?

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