Glossary
Quality Risk Management (QRM)
A systematic process for assessing, controlling, communicating, and reviewing quality risk across the product lifecycle.
Source · ICH Q9(R1), Quality Risk Management, §§3–4 and Glossary
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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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 -
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 -
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
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q9(R1), Quality Risk Management, §§3–4 and GlossaryGRM Regulatory Glossary
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