Facing a GDP inspection, a customer audit, or a new warehouse or cold room? A temperature mapping study by Temperature Mapping Europe gives you the audit-ready substantiation that inspectors and MA-holders expect, for your 15-25 °C storage, 2-8 °C cold rooms and API zones.
GDP temperature mapping is a documented study that measures whether every product location in a warehouse or cold room stays within its required temperature range, typically 15-25 °C or 2-8 °C, over a representative period including seasonal extremes. The study identifies hot and cold spots, justifies where fixed monitoring sensors should be placed, and produces the qualification dossier that GDP inspectors and MA-holders expect.
A mapping study is not documentation for its own sake. It exists to give you a defensible answer to the three questions that come up in almost every GDP inspection of a warehouse or cold room.
Without mapping, sensor positions tend to be chosen by convenience: near a door, on a pillar, wherever the cable reached. A mapping study replaces that with data. The sensor sits where the hot or cold spot actually is, and you can show the graph that proves it.
A single week of measurement in October says little about August. GDP expects representative conditions, which for most European warehouses means a summer campaign and a winter campaign, or a documented justification for why one season is enough.
Cold rooms recover after a door movement, but how deep the excursion goes and how long recovery takes depends on load, product height and airflow. Mapping quantifies this and translates it into the excursion limits your monitoring alarms should use.
The three questions above are just the start. Our free audit-readiness check runs your temperature-mapping and monitoring documentation past the control points that GDP and GMP auditors actually raise, tailored to your room type: warehouse, cold room, freezer or refrigerator. In five to ten minutes you receive a PDF report showing where your file is strong, and where an inspector might raise a finding.
Grounded in EU GDP, GMP Annex 15, WHO and ISPE, plus 37 concrete findings from 58 Dutch IGJ inspection reports.
The mapping study is the same. What differs is how much your team performs, and how much we take over. Pick the level that fits your internal capacity and audit risk appetite.
Loggers ship as a plug-and-measure case with calibration certificates. See what is in the case.
At Temperature Mapping Europe, your project is handled by people with real industry experience. Our approach is technically sound, but above all focused on what is needed in practice to assess and substantiate storage conditions properly.
We have extensive hands-on experience in quality management within EU-GMP/GDP environments for pharmaceutical manufacturing and distribution. This experience includes serving as a Responsible Person / Designated Person and leading validation and qualification programmes in highly regulated environments.
The people assessing your space come from industry. They understand both the guidance and how temperature mapping is assessed in practice by QA, auditors and inspectors.
Temperature Mapping Europe is an independent company, not a manufacturer, distributor or label of any equipment supplier. We sell no monitoring systems of our own and choose data loggers on a brand-neutral basis. Our approach follows ISPE, WHO, GDP, GMP and HACCP guidance, independent of any supplier.
The same person helps define the measurement setup, assesses the space, processes the data and writes the report. That gives you short lines, fast planning and one fixed point of contact.
The number of loggers, the study duration and the risk zones depend on which temperature range applies to your product. Below is the typical scope for GDP storage; the exact plan is set in the mapping protocol, on a risk-based rationale per WHO TRS 961 and ISPE GPG.
For medicinal products and APIs at controlled room temperature. Typical scope for a European GDP warehouse: a grid of loggers every 5 to 10 metres, at multiple heights across the working height, over at least a full measurement week per season. Larger facilities easily reach dozens of measurement points.
For refrigerated medicinal products and samples. Typical scope for a walk-in cold room: 9 to 15 measurement points depending on volume, with extras at the door and near the evaporator, over at least a full measurement week with a representative delivery pattern.
Measurement points are selected based on product locations, airflow, doors, height differences and existing temperature data.
A GDP mapping dossier should make it clear why the study design was logical, what the data show and how routine monitoring follows from the results.
"Placing the loggers ourselves and still receiving a fully substantiated dossier was exactly what we needed. Everything was arranged at short notice."Operations manager, pharmaceutical distribution
Before requesting a quote, use the free 3D mapping tool to sketch your warehouse or cold room. You get a proposed sensor layout, an estimated number of loggers and a first indication of the study scope, so the consultation starts with a concrete picture instead of a blank sheet.
Mapping is especially useful when temperature control must be demonstrable or when the situation has changed.