Glossary

Quality Risk Management (QRM)

A systematic process for assessing, controlling, communicating, and reviewing quality risk across the product lifecycle.

Related sections

ICH Q9(R1) §§4–5, 7 EU GMP Part I Chapter 1 §1.12

Related terms

Risk Assessment59 casesRisk ControlRisk Review

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

  1. Action taken/proposed by the NCA: Others Market actions should be determinated by each Member State based on QRM principles in order to avoid shortages of medical products in the market.
    EMA · EU GMP NCR (EudraGMDP) · 2025-07-11
  2. The system has not been implemented and properly documented, and the monitoring of its effectiveness is not based on real data and quality risk management.
    EMA · EU GMP NCR (EudraGMDP) · 2025-12-16
  3. Action taken/proposed by the NCA: Recall of batches already released A recall of products should be considered using QRM principles.
    EMA · EU GMP NCR (EudraGMDP) · 2019-10-17
See 13 findings that mention this term

Source

ICH Q9(R1), Quality Risk Management, §§3–4 and Glossary
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