Glossary
Management Review
The procedure by which senior management periodically reviews whether the quality system is working and decides the action needed.
Source · ICH Q10 (2008), §4.1 Management Review of the Pharmaceutical Quality System
Details
ICH Q10 separates what goes in from what must come out. What goes in is the results of regulatory inspections and commitments made to authorities, periodic quality reviews, complaints and recalls, the conclusions of process performance and product quality monitoring, the effectiveness of changes and CAPA, and follow-up from the previous review; what comes out is improvements to processes and products, provision of resources and training, and the capture and dissemination of knowledge. What is examined is not the record that a meeting was held but what was decided there and whether the decision was implemented; the review may be split into several levels according to the size of the company, provided there is a route by which significant quality issues reach the top.
Related sections
Related terms
Real inspection findings
See 10 findings whose text contains this termCounted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q10 (2008), §4.1 Management Review of the Pharmaceutical Quality SystemGRM Regulatory Glossary
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