Mapping and qualification

All spaces and devices where temperature-sensitive products are stored must be regularly qualified and mapped.

Qualification is a documented procedure of verification that the observed system in real working conditions and in the prescribed operating range functions efficiently and repeatably and achieves the expected and prescribed results.

Mapping includes monitoring the existing condition of the space with calibrated high-precision equipment at multiple monitoring points in order to obtain the most detailed view of the actual condition of the storage conditions.

Our mapping methods are in accordance with the GMP and GDP guidelines, the guide “Temperature mapping of storage areas” – Annex 9: Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products (World Health Organization, 2014) and established practice in the field of pharmaceutical industry. The devices we use in mapping are regularly calibrated in our calibration laboratory at at least five points of temperature and relative humidity.