
Controlled Environments
EU GDP · WHO TRS 961 · Cold chain · Validated
GDP-validated storage with qualification, continuous monitoring and auditable traceability.
In detail
A cold room is not GDP storage. The difference lies in qualification, continuous monitoring and the chain of traceability an auditor can follow from product release back to the storage environment. We design and build validated storage environments: cold rooms, controlled room temperature warehouses and specialised storage under EU GDP Guidelines (2013/C 343/01) and WHO TRS 961 and TRS 1025. Every facility includes thermal mapping studies, alarm management and validation protocols that support regulatory submission.
The temperature record of every batch is defensible before any competent authority — not because the room was cold, but because qualification documented that it was, continuously, within the specified range, with calibrated instrumentation and a rehearsed alarm response protocol. That is GDP storage. That is what we build.