Why Perform GMP Temperature Mapping?
Clause 3.19 of the PIC/S GMP guide states:
“Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.”
What will happen if…….
-Your facility lost power over a weekend?
Would you be set back months or even years in research and development?
-Your refrigerator motor short circuits?
Would you have to discard valuable material or otherwise sellable inventory?
-You were faced with a surprise audit?
Is your QA team ready? Do you readily have the documentation to avoid a deviation?
Facility, warehouse, laboratory equipment and storage area temperature/RH mapping (validation) services
GAMP Services provides Turnkey ((As a project from protocol to report) thermal validation/mapping in Entire facility which includes clean rooms, QC laboratory and warehouses as well as freezer rooms, cold rooms, temperature-controlled storage areas, quarantine areas and receiving and loading bays etc.
Thermal validation/ mapping is performed as per WHO guidelines, PICS, Food and Drug Administration (FDA) or as per ICH.
Temperature mapping/validation is performed using 21 CFR part -11 compliance software.