No long standard text, but a practical translation. Choose the source or question that fits your situation: GDP, IGJ, WHO, ISPE, pharmacies, HACCP, medical devices, summer and winter mapping or data logger rental.
There is usually no single legal formula that defines every temperature mapping setup. GDP, GMP, WHO and ISPE guidance expect a risk-based, predefined approach with acceptance criteria, calibrated loggers and a report that justifies monitoring positions.
Walk through the key points from GDP, GMP and HACCP with the free audit readiness check and see where work may remain.
Run the audit readiness check All toolsTemperature mapping touches multiple sectors. For each source, we show who it is relevant for and what it means in practice for mapping, monitoring and reporting.
Medicinal-product storage and distribution
Important for storage rooms, warehouses and distribution points where medicinal products are stored under controlled temperature conditions.
Wholesalers, manufacturers and GDP practice
The IGJ FAQ helps interpret the European GDP guideline in Dutch practice. We use this source as a practical explanation of GDP expectations.
Storage areas, warehouses and temperature zones
WHO is especially practical for carrying out mapping studies: temperature profile, loading, seasonal influence and assessment of storage zones.
Pharma, labs, QA and controlled temperature chambers
ISPE supports a risk-based lifecycle approach to qualification, mapping, monitoring, changes and periodic review.
Pharmacies, GP practices, clinics and vaccines
For medical refrigerators, the focus is often 2 to 8 °C, a suitable refrigerator, calibrated loggers, recording and clear actions when deviations occur.
Food companies, medical devices and IVDs
GDP is not the correct framework for everything. For food, HACCP and food safety apply. For devices and IVDs, MDR, IVDR and product-specific storage conditions apply.
The guidelines do not always give one exact number of loggers or one fixed frequency. They require a logical, justified approach that fits your room, products and risk.
Define measurement points, duration, acceptance criteria, load condition and any test scenarios in a short mapping protocol before the study starts.
Use traceably calibrated data loggers. We work with calibrated loggers for audit-ready measurement data.
Assess the actual temperature profile, the warmest and coldest points, excursions and time outside specification. The highest and lowest temperatures matter, not an average or MKT.
Place fixed monitoring equipment based on the mapping results. Not by feeling, but based on the risk locations found.
Repeat mapping after relevant changes, unusual trends, repairs, relocation or when seasonal influence has not yet been justified.
Logger rental is useful when you want to perform the measurement yourself without buying equipment for limited use.
Not always. It depends on how sensitive your space is to external conditions. For ambient storage, warehouses, loading docks, external walls, windows or variable HVAC load, seasonal influence can be relevant. For cold rooms and freezer rooms, two-season mapping is often less automatic, but it still needs to be assessed.
Relevant with heat load, solar radiation, warm outside air, frequent door movements or a cooling system that has to work harder in summer.
Relevant near cold external walls, loading bays, draughts, low outside temperature or rooms where cold zones may occur.
Document why one season is sufficient, or why a second seasonal mapping is needed. That justification is often as important as the measurement itself.
Practical answers to common questions about GDP, IGJ, summer and winter mapping, measurement points, data loggers, calibration and reporting.
We use the sources below as the guideline basis. We do not reproduce paid standards verbatim, but translate them into a practical and justified mapping approach.
Briefly describe what you store and where. We translate the guidelines into a practical approach for your fridge, freezer, cold room or storage area.