Substantiate storage conditions in 15-25 °C warehouses, 2-8 °C cold rooms, dispatch areas and API storage with a practical audit-ready mapping dossier.
Temperature mapping of a GDP warehouse shows whether all relevant product locations remain within the defined temperature limits. It identifies hot and cold spots, substantiates fixed monitoring positions and provides documentation for inspection, audit and internal qualification.
Use the tool hub or create a 3D measurement-point proposal directly. It helps make room layout, product zones, doors and risks concrete before you choose a service level.
A single average room temperature is not enough. The study design should reflect racks, doors, airflow, loading, seasonal conditions and actual product locations.
For medicinal products and APIs stored at controlled room temperature. Mapping assesses rack height, external walls, solar load, HVAC, loading pattern and weekend or night operation.
For refrigerated medicinal products, samples or temperature-sensitive materials. Mapping focuses on door zones, evaporator, return air, loading, product height and sensor position.
Under GDP, storage areas should be demonstrably suitable for the required temperature conditions. Mapping links storage qualification to routine monitoring.
The GDP guideline expects temperature mapping of storage areas under representative conditions, including seasonal variation.
A mapping dossier helps demonstrate that storage and monitoring are justified for inspection, customer audit or internal review.
Routine monitoring should follow the mapping results, especially at locations that experience temperature extremes.
Changes, repairs, layout changes or recurring deviations may require remapping or requalification.
Traceable substantiation of storage conditions is important for APIs, medicinal products and supplier qualification.
Summer and winter can reveal different worst-case locations. The approach should be risk-based.
Measurement points are selected based on product locations, airflow, doors, height differences and existing temperature data.
Choose how much your team performs internally. The scope is aligned with the area, temperature limit, audit pressure and required dossier depth.
You rent calibrated data loggers and perform the measurement yourself. Suitable when you already have an internal approach and mainly need reliable instruments.
We provide the protocol, risk assessment and measurement plan. You measure yourself. Afterwards you receive analysis, conclusion, certificates and monitoring advice.
We perform the mapping on site, analyse the data and deliver the full dossier. Suitable for audit pressure, complexity or limited internal capacity.
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
Mapping is especially useful when temperature control must be demonstrable or when the situation has changed.