GDP guide · Sources checked October 2026
GDP temperature excursion records and monitoring evidence
GDP temperature excursion records show that a product was outside its labelled storage conditions, what was done about it and who decided what happened to the product: the EU GDP guidelines call for alarms when storage goes outside pre-defined conditions and for a procedure to investigate and handle temperature excursions. GDP temperature monitoring records also include mapping, calibration and maintenance evidence.
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GDP temperature monitoring records
What the guidelines say about temperature
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| Topic | What the guideline says | Source |
|---|---|---|
| Mapping | An initial temperature mapping exercise of the storage area before use, with monitoring devices placed where the extremes occur. Repeat according to a risk assessment or after significant changes to the facility or temperature control equipment | EU GDP guidelines, section 3.2.1, checked October 2026 |
| Calibration and alarms | Equipment that controls or monitors storage is calibrated at defined intervals, traceable to a national or international standard. Alarms should alert on excursions from pre-defined conditions, be set at appropriate levels and be regularly tested | EU GDP guidelines, section 3.3, checked October 2026 |
| Maintenance and calibration records | Records of repair, maintenance and calibration of key equipment, including cold stores, are made and the results retained | EU GDP guidelines, section 3.3.2, checked October 2026 |
| Excursion during transport | A deviation such as a temperature excursion during transport should be reported to the distributor and recipient, and a procedure should be in place for investigating and handling temperature excursions | EU GDP guidelines, section 9.2, checked October 2026 |
| Transport monitoring equipment | Monitoring equipment in vehicles and containers is maintained and calibrated at regular intervals, at least once a year. Vehicle mapping should reflect representative conditions and seasonal variation | EU GDP guidelines, sections 9.2 and 9.4, checked October 2026 |
| Evidence for customers | If requested, customers should be given information showing products complied with temperature storage conditions | EU GDP guidelines, section 9.4, checked October 2026 |
| Records made at the time | Records should be made when each operation is undertaken, and alterations signed and dated | EU GDP guidelines, section 4.2, checked October 2026 |
Sources checked October 2026. Legislation and guidance change: open the linked source before relying on any row. This page is general information, not legal or regulatory advice; your Responsible Person and the MHRA decide what applies to your licence.
GDP temperature excursion records: a practical list
What an excursion record should show
A practical reading of the guidelines, not a legal test. The guidelines do not set a decision rule for product that has been outside its range; take advice from the manufacturer or marketing authorisation holder and your Responsible Person.
The Responsible Person is responsible for deciding the final disposition of returned, rejected, recalled or falsified product (EU GDP guidelines, section 2.2, checked October 2026). For the deviation and CAPA record, read GDP deviation and CAPA records.
- Product, batch, quantity and location affected.
- The labelled storage range, the readings that fell outside it, and for how long, with the source of the data.
- Whether an alarm fired, who was alerted and when.
- Immediate action: segregation or quarantine of the stock.
- The investigation and likely cause, such as equipment failure, a door left open or transport delay.
- The decision on the product, who made it, and the information it was based on.
- Customers or recipients notified where the product had already left.
- A CAPA, linked to your deviation record.
GDP inspection findings on temperature
What the MHRA has cited
Examples from the MHRA’s published 2016 deficiency data, paraphrased.
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| Finding (paraphrased) | Why it matters for the record | Source |
|---|---|---|
| Mapping not adequate | Mapping had not established suitability of the storage area or the position of thermometers, and no conclusion was drawn | MHRA GDP deficiency data 2016, checked October 2026 |
| Gaps in records | Considerable gaps in contemporaneous temperature records, and readings added after the event to fill them | MHRA GDP deficiency data 2016, checked October 2026 |
| Calibration | A warehouse thermometer not calibrated across its operating range; uncalibrated equipment used to monitor transport temperature | MHRA GDP deficiency data 2016, checked October 2026 |
| Transport risk assessment | Ambient products shipped without a risk assessment showing temperature was maintained for the whole journey | MHRA GDP deficiency data 2016, checked October 2026 |
Sources checked October 2026. Legislation and guidance change: open the linked source before relying on any row. This page is general information, not legal or regulatory advice; your Responsible Person and the MHRA decide what applies to your licence.
Worked example (fictional)
One excursion in a cold room
A fictional wholesaler and event, for illustration only.
1
Alarm
At 02:10 the monitoring system at Example Medicines Wholesale Ltd alerts the on-call person that the cold room is above its upper limit.
2
Contain
The on-call person attends, finds the door seal faulty, moves stock to a second qualified unit and segregates the affected shelves.
3
Gather the data
The logger download shows the room was out of range for a recorded period; the team attaches it to the record with the calibration certificate for the probe.
4
Decide
The Responsible Person asks the manufacturers for stability information on the affected lines and records the decision and the reasoning for each product.
5
Close
A CAPA repairs the seal and adds the door check to the daily routine; the deviation goes to the next management review.
Related guides
Read next
Excursions feed the deviation record.
Deviation and CAPA records, GDP documentation requirements and GDP compliance software compared, which includes a temperature-monitoring product.
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FAQ
Common questions
What counts as a temperature excursion in GDP?
The guidelines refer to excursions from pre-defined storage conditions and to deviations such as temperature excursions in transport. The limits come from the manufacturer’s labelled conditions.
How often must monitoring equipment be calibrated?
In storage, at defined intervals based on a risk and reliability assessment; for transport monitoring equipment the guidelines say at regular intervals, at least once a year.
Can I use temperature data from a data logger as a record?
The guidelines require records of temperature monitoring and of calibration and maintenance, in paper or electronic form. Computerised systems should be validated or verified. Ask your Responsible Person what your system needs.
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