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.
A temperature excursion is any period during which a monitored temperature is outside its defined limits. Under GDP it is handled as a deviation: the product is quarantined or held, the excursion characterised (magnitude, duration, product affected), impact assessed, a release or rejection decision made, and root cause and corrective action considered.
Assessing impact
- Consult the manufacturer's stability data or excursion allowances for the product.
- Characterise the excursion from monitoring data: peak, duration, cumulative time out of range.
- Mean kinetic temperature can summarise the thermal exposure of a period, but it is not a substitute for product-specific data.
- Record the decision and who made it.
Monitoring data quality matters here: gaps, sensor faults and uncertainty at the limit can change the characterisation of an excursion, so the data should be checked before the assessment.
Frequently asked questions
- Is a two-minute door-opening spike an excursion?
- Only if the protocol defines it as one. Many organisations define excursions by duration as well as limit, based on product data — the definition must be written down before it is needed.
References
- [1]EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
- [2]WHO Technical Report Series 961, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (2011)
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
Have a question on this topic?
Ask ValiTrac AI and see the evidence and calculation behind the answer.
Ask ValiTrac AIFree calculator: MKT & logger data check
Paste logger readings and get MKT per ICH Q1A(R2) alongside min, max, mean and out-of-limit runs with durations.
Open the calculatorRelated articles
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.
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.