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.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
EU GDP (2013/C 343/01)WHO TRS 961 Annex 9
DOCUMENT TYPE
Risk Assessment
LAST UPDATED
January 2025
PURPOSE

An assessment that decides, on documented stability data, whether product exposed to an out-of-range condition in storage or transport remains fit for use. The decision belongs to a qualified person under the organisation's quality system; this template exists to make sure the decision is made on stability evidence and cumulative exposure rather than on the appearance of the product or the convenience of the answer.

What's Inside

✓Excursion event description — magnitude, duration, and where in the chain it occurred
✓Product identification, batch, quantity affected, and the labelled storage conditions
✓Stability data reference, including the specific studies and conditions relied on
✓Mean kinetic temperature or cumulative exposure calculation, with the inputs and method shown
✓Impact assessment against approved limits, stating what the data supports and what it does not
✓Disposition decision with the name and role of the person making it
✓CAPA and preventive actions addressing the cause of the excursion, not only the affected batch

How to Use It

1Record the excursion magnitude and duration from the monitoring record, not from recollection
2Pull the labelled storage conditions and the specific stability studies that cover them
3Calculate mean kinetic temperature where cumulative exposure applies, and show the inputs so the calculation can be checked
4Decide impact against the approved stability limits, and say plainly where the data does not extend far enough to support a decision
5Record the disposition and the qualified person who made it, with the scientific basis stated
6Address the cause through CAPA — a repeating excursion is a chain problem, not a batch problem
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) requires that medicinal products are stored and transported within labelled conditions and that deviations are assessed before product is used, and WHO TRS 961 Annex 9 sets out the model guidance on storage and transport of time- and temperature-sensitive products. Neither authority decides whether your batch is fit for use; that determination rests with the qualified person under your quality system, on your stability data. This template documents the basis of that decision and does not substitute for it.

MAPPED STANDARDS
EU GDP (2013/C 343/01)WHO TRS 961 Annex 9
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