Checklist · 16 items
Temperature excursion response checklist
Contain, characterise, assess, decide, learn — the steps and records an excursion deviation needs.
Based on: EU GDP chapters 3 and 9 · WHO TRS 961 Annex 9 · ICH Q1A(R2) (MKT)
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Immediately
Characterise
Assess and decide
Close and learn
General technical guidance written against the cited sources. Adapt it to your procedures; it is not a substitute for the applicable standard or a qualified reviewer's judgement.
Background reading
Handling temperature excursions in storage and distribution
An excursion is a deviation: contain, record, assess product impact against stability data, decide, and learn. The record must show all five steps.
Mean kinetic temperature (MKT): what it is and when to use it
MKT is a single temperature that represents the cumulative thermal stress of a varying temperature history, weighted by the Arrhenius relationship. It is useful for storage assessment, not for hiding excursions.
Deviations and CAPA for environmental control failures
An excursion, a failed calibration or a mapping failure is a deviation. Classify it, investigate root cause proportionately, and close it with an action that prevents recurrence.
Alarm limits vs acceptance limits: setting them correctly
Acceptance limits come from the product; alarm limits sit inside them to give time to act; alert (warning) limits sit inside those. Uncertainty and delay decide the gaps.