For WDA holders and pharmaceutical distribution
Show the MHRA your temperature control, not just tell them
Under GDP the MHRA expects monitoring placed where your mapping found the extremes, calibration traceable to national standards and alarms on every excursion. We help you evidence all three on the day.
- Sensors placed on your mapping results
- Traceable or UKAS calibration for every sensor we supply (UKAS accredited calibration laboratory No. 10723 for temperature)
- Excursion records your Responsible Person can sign off
18.4°C
What inspectors ask you
The rules that apply to your stores and vehicles
A GDP inspection follows the guidelines chapter by chapter. These are the parts that touch temperature.
- GDP 3.2.1
Mapping before use
Each storage area mapped under representative conditions, and monitoring placed at the extremes it found.
Read the guide - GDP 3.3
Calibrated, alarmed equipment
Calibration at defined intervals, traceable to national standards, and alarms that are set and tested.
Read the guide - GDP 3.3.1
Validated computerised systems
A validated monitoring system: the Sematics platform validated under a validation lifecycle aligned to EU GMP Annex 11, with the evidence for your supplier assessment, your configuration qualified (URS, DQ, PQ), controlled access, and backups kept for at least five years.
Read the guide - GDP 9.2
Transport
Storage conditions held in transit and a written procedure for investigating excursions.
Read the guide
GDP, chapter by chapter
Which part of GDP each service evidences
| Control | Mapping | Monitoring | Calibration | Validation |
|---|---|---|---|---|
| 3.2.1 Storage areas mapped | ✓ | · | · | · |
| 3.3 Calibrated, alarmed equipment | · | ✓ | ✓ | · |
| 3.3.1 Validated computerised systems | · | ✓ | · | ✓ |
| 9.2 Conditions held in transport | · | ✓ | ✓ | · |
A summary to plan with, not official guidance.
93%
of closed incidents on Sematics in 2026 with the full record where it is required: root cause, corrective and preventive action
What we monitor
Every place your stock sits, on one record
Warehouses and ambient stores
Monitored at the hot and cold spots your mapping study found, with seasonal changes in view.
Cold rooms and 2 to 8 °C stores
Alarms before product goes out of range, with door contacts where an open door is the usual cause.
Pharmaceutical fridges and freezers
Each unit with its own limits, alarm route and calibration certificate.
Vehicles
The same platform as the warehouse, so a delivery's record runs from store to drop.
“Sematics has completely taken the stress out of temperature monitoring.”
Services for this sector
One team for monitoring, mapping, calibration and support
Temperature monitoring
Wireless sensors, alarms that reach a person and an audit trail of who acted.
Explore the serviceTemperature mapping
A managed study, from protocol to report, with probe positions you can defend.
Explore the serviceUKAS calibration
Temperature calibration in our UKAS accredited calibration laboratory No. 10723, or on your site.
Explore the serviceValidation (IQ OQ PQ, DQ)
Hardware IQ and OQ, the platform validated by Sematics, and your URS, DQ and PQ.
Explore the service
Free checklist
MHRA GDP and Green Book temperature checklist
One A4 page on what the GDP guidelines expect for storage, equipment, computerised systems and transport, and what to record during an excursion.
Questions
What people in your sector ask us
Does GDP require continuous monitoring?
The guidelines don't use the word. They do require alarms that alert you to excursions from pre-defined storage conditions (3.3), which a manual check can't do overnight or at a weekend.
Can you map our warehouse?
Yes. Temperature mapping is a JTF managed service: we plan, run and report the study, then place the monitoring on its results. Our UKAS accreditation covers temperature calibration, not mapping.
Do you cover vehicles?
Yes. GDP 9.2 expects storage conditions held in transit and a procedure for transport excursions. We monitor vehicles on the same platform as the warehouse.
Will our RP see what happened during an excursion?
Yes: the readings, the alarm, who responded and what they did, on one record they can review and sign off.
Is the monitoring system validated for GDP?
In three parts. JTF qualifies the hardware at your site (IQ and OQ), Sematics validates the platform against its requirements and verifies each release according to its risk, and you qualify your configuration and use (URS, DQ and PQ) with our support, under a quality and technical agreement. See validation.
20-minute compliance check
How would you answer an MHRA inspector on temperature?
In 20 minutes we go through mapping, monitoring, alarms, calibration and excursions with you. You get the gaps in writing. No product tour.