For GMP manufacturers, CDMOs, API sites and clinical supply
Storage conditions provided, checked and monitored, and proven
EU GMP asks for special storage conditions to be provided, checked and monitored (Chapter 3, 3.19) and for the equipment that holds them to be qualified (Annex 15). JTF already monitors 350+ UK sites, with every reading, alarm and response on one record your QA team and QP can review.
- Stores, cold rooms, stability chambers, QC fridges and −80 °C freezers on one platform
- Mapping studies for your Annex 15 qualification, run as a JTF managed service
- Calibration for every sensor we supply: traceable to national standards as standard, or UKAS accredited where you need it (temperature in our own UKAS accredited calibration laboratory No. 10723; other parameters through accredited partners)
- Annex 11 evidence for the monitoring system, and a clear split of who proves what
25.1°C
What inspectors ask you
The parts of GMP that touch temperature
MHRA and HPRA inspectors work from the EU GMP Guide, reproduced for the UK in the MHRA's Orange Guide. These are the clauses behind most temperature questions.
- GMP 3.19, 5.7
Storage conditions monitored
Special storage conditions provided, checked and monitored, for materials, intermediates, quarantined and released product.
Read the guide - GMP 3.41
Calibrated at defined intervals
Measuring, recording and control equipment calibrated and checked at defined intervals, with records. (Our recommendation: when a calibration fails, assess the readings back to the last good calibration.)
Read the guide - Annex 15
Qualified, then kept qualified
URS, DQ, IQ, OQ and PQ for rooms and chambers, requalification at a justified frequency, and change control that asks whether the mapping still holds.
Read the guide - GMP 6.29, ICH Q1A
Stability chambers
Chambers qualified and maintained, actual temperature and humidity monitored, and excursions over 24 hours written into the study report.
Read the guide - Annex 11
A validated monitoring system
Validated for your intended use, with an audit trail someone reviews, controlled access and data that stays readable for the retention period.
Read the guide - Annex 1
Sterile manufacture
Monitoring requirements in the URS, alarm events trended, and any alarm delay justified in the contamination control strategy.
Read the guide
GMP, clause by clause
Which GMP expectation each service evidences
| Control | Mapping | Monitoring | Calibration | Validation |
|---|---|---|---|---|
| 3.19 Storage conditions monitored | ✓ | ✓ | · | · |
| 3.41 Calibrated at defined intervals | · | · | ✓ | · |
| Annex 15 Qualified and requalified | ✓ | · | ✓ | · |
| 6.29 Stability chambers | ✓ | ✓ | ✓ | · |
| Annex 11 Validated monitoring system | · | ✓ | · | ✓ |
A summary to plan with, not official guidance. Mapping supports your qualification; the qualification decision is yours.
- ICH Q1A(R2) tolerance
- Alert limits inside it
Ultra-low freezers sit inside it. LN2, humidity and CO₂ go to accredited partners.
What we monitor
Every place a material, sample or batch waits
Warehouses, receiving and quarantine
Monitored at the extremes your mapping found, with humidity where materials such as capsule shells need it, and the same record for quarantined, released and rejected stock.
Cold rooms and 2 to 8 °C stores
Recording probes independent of the room's own controller, with door contacts where an open door is the usual cause.
Stability chambers
Temperature and humidity recorded against the ICH tolerances, so an overnight failure is found in minutes, not at the next pull point.
QC lab fridges, freezers and sample stores
Reference standards, reagents, and retention and reference samples, each unit with its own limits and alarm route.
−80 °C freezers and LN2 vapour-phase stores
PT100 probes for ultra-low freezers, cell and gene therapy material and cryogenic stores. Below −90 °C, calibration goes through accredited partners.
Incubators
Temperature monitored directly, and CO₂ read from a transmitter through our analogue input. CO₂ calibration goes through accredited partners.
Shipping and clinical supply
Vehicles and shippers on the same platform as the warehouse, so a batch's record runs from the store to the trial site or customer.
“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
Questions
What people in your sector ask us
Does GMP require continuous temperature monitoring?
EU GMP says special storage conditions should be provided, checked and monitored (3.19) and environmental data recorded so it can be trended (6.9); it doesn't use the word continuous. Spot readings can't show what happened between checks, which is why the MHRA cited twice-daily readings with no max/min data as a deficiency. In Ireland the HPRA's temperature guide, which includes manufacturers in its scope, says a continuous monitoring system is required for storage.
How often should we requalify a stability chamber or cold room?
Annex 15 asks for evaluation at an appropriate frequency, with any fixed period justified (4.1 and 4.2). It sets no number. Our risk-based recommendation, with the reasoning, is in the GMP storage, mapping and monitoring guide.
Can you map our chambers, cold rooms and warehouse?
Yes. Temperature mapping is a JTF managed service: we write the protocol for your approval, run the study and report it, and the results feed your own OQ and PQ. Your qualification decisions stay with your QA team. Our UKAS accreditation covers temperature calibration, not mapping.
Is the monitoring system validated for GMP?
In three parts. Sematics validates the platform under a validation lifecycle aligned to EU GMP Annex 11, and gives you the evidence for your supplier assessment; JTF qualifies the hardware it installs (IQ and OQ), and you qualify your configuration and use (URS, DQ and PQ) with our support. The platform's validation is written for storage and transport monitoring of temperature, humidity and door state, so for a GMP site you assess that evidence against your own intended use, as Annex 11 and the MHRA's data integrity guidance expect. See validation.
Do you calibrate humidity, CO₂ and LN2 probes?
Yes, through accredited partners. Our own UKAS accredited calibration laboratory No. 10723 calibrates temperature only, from −90 to +135 °C in a dry block and −35 to +40 °C in an air chamber, in the lab or on site.
Can you monitor cleanroom pressure differentials or particle counts?
We don't supply particle counters or differential pressure sensors. Cleanroom classification and particle monitoring follow Annex 1 and ISO 14644, usually through a dedicated environmental monitoring system. Our analogue input can read a signal from a third-party transmitter, so ask us to confirm it fits your instrument and your validation before you plan on it.
Do you cover clinical trial supply?
Yes, for storage and transport. The EU guideline on IMP handling and shipping says temperature monitoring of transport and storage is necessary and the records should be reviewed at delivery. We monitor depots, vehicles and shippers on one platform, so the record travels with the batch.
Sources
- EudraLex Volume 4, EU GMP Part I, Chapter 3: Premises and Equipment (in operation 1 March 2015)
- EudraLex Volume 4, EU GMP Part I, Chapter 6: Quality Control (in operation 1 October 2014)
- EudraLex Volume 4, Annex 15: Qualification and Validation
- EudraLex Volume 4, Annex 11: Computerised Systems
- EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products (2022, in operation 25 August 2023)
- ICH Q1A(R2) Stability testing of new drug substances and drug products (EMA scientific guideline; defines mean kinetic temperature)
- The Human Medicines Regulations 2012, regulation 37 (manufacturing and assembly: the duty to comply with GMP)
- Pharmaceutical Press: The MHRA Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors)
20-minute compliance check
Would your stability chamber records satisfy an inspector?
In 20 minutes we go through storage, monitoring, mapping, calibration and the monitoring system's validation with you. You get the gaps in writing. No product tour.