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RISK ASSESSMENTREFERENCE OUTLINE
Temperature Excursion Assessment
Cold-chain temperature excursion assessment evaluating product against stability data and mean kinetic temperature to reach a science-based disposition. Maps to EU GDP (2013/C 343/01) and WHO TRS 961 Annex 9.
REGULATIONS MAPPED
EU GDP (2013/C 343/01)WHO TRS 961 Annex 9
DOCUMENT TYPE
Risk AssessmentLAST UPDATED
January 2025PURPOSE
A temperature excursion assessment that evaluates, on documented stability data, whether product exposed to an out-of-range condition in storage or transport remains fit for use.
What's Inside
✓Excursion event details and duration
✓Product and stability-data reference
✓Mean kinetic temperature calculation
✓Impact decision against approved limits
✓Disposition and CAPA linkage
How to Use It
1Record the excursion magnitude and duration
2Pull the product’s stability and labelled conditions
3Calculate MKT where cumulative exposure applies
4Decide impact against approved stability limits
5Document disposition and preventive actions
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Excursion Event Description
2Product and Labelled Storage Conditions
3Stability Data Reference
4Mean Kinetic Temperature / Cumulative Exposure
5Impact Assessment and Decision
6Disposition
7CAPA and Preventive Actions
REGULATORY CONTEXT
EU GDP (2013/C 343/01) and WHO TRS 961 Annex 9 require excursions to be assessed against stability data before release or use. This template documents that science-based disposition.