The Board of the Eurasian Economic Commission has adopted Recommendation No. 8 dated April 20, 2026, approving guidelines for temperature mapping of medicine storage areas within the Eurasian Economic Union. The document harmonises approaches to controlling temperature distribution in pharmaceutical storage areas and supports compliance with Good Distribution Practice requirements in the EAEU.
The guidelines apply to medicine manufacturers, wholesale distributors, pharmacy and medical organisations, pharmaceutical inspectorates, and authorised expert bodies of EAEU member states. They cover warehouses, cold rooms, freezers and other temperature-controlled areas used for storing medicines.
Temperature mapping is defined as a documented study of temperature distribution within a storage area, including the identification of hot and cold spots. The guidelines describe mapping as part of the qualification of storage areas and as a tool to determine whether temperature-sensitive medicines are stored under appropriate conditions.
The document recommends temperature mapping for each temperature-controlled storage area before it is put into operation. Periodic re-mapping is recommended based on change control and risk analysis, and when unexplained temperature deviations are detected.
The guidelines set out the main stages of the process: preparing a temperature mapping protocol, performing the mapping study, preparing the mapping report, and implementing corrective actions where necessary. They also include recommendations for data loggers, acceptance criteria, mapping methodology, sensor placement, documentation and personnel training.
For warehouses and other controlled-environment storage rooms, the mapping study should generally run for at least seven consecutive days. For controlled-environment refrigeration equipment, including cold rooms and freezers, the study may last from 24 to 72 hours or longer if required.
