Glossary
Critical Intervention
An inherent or corrective intervention that enters the critical zone.
Source · EudraLex Volume 4, Annex 1 (2022), §11 Glossary: Critical intervention
Details
A critical intervention can disturb first air and sterile surfaces, so it must be defined in advance, risk assessed, and minimised. Inspections cite unplanned interventions that are not reflected in the batch record, the APS, or environmental monitoring, and unclear follow-up after an intervention. Check the intervention list, the aseptic technique SOP, the APS scenarios, the batch record, and the monitoring results taken at the time of the intervention.
Related sections
Related terms
Real inspection findings
See 3 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
EudraLex Volume 4, Annex 1 (2022), §11 Glossary: Critical interventionGRM Regulatory Glossary
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