|All new temperature-controlled storage areas must be temperature-mapped as part of a fully documented verification process, before the installation is commissioned and handed over by the installer. Until this has been done, it is not safe to store TTSPPs in such areas.
The temperature mapping procedures should:
Subsequent mapping exercises must also be carried out on a periodic basis – for example, every three years – in order to demonstrate continuing compliance.
In addition mapping should be carried out whenever significant modifications are made to the store.
Examples include changes in the pattern of use that may increase loading or affect air circulation, or changes to the refrigeration equipment, such as an alteration to the set point. Finally a remapping exercise may be justified whenever an analysis of temperature and/or humidity monitoring records show unexplained variability outside normal operating limits.
All mapping exercises should be fully documented in order to demonstrate compliance to management, clients and the regulatory authorities.
Section 4.7 of WHO Technical Report Series No. 961, 2011