Government Gazette Board Notice 50, of 27 February 2015, Section 2.3.5.3(c).
Internal air temperature distribution in the storage area must be mapped annually. This must be done annually under conditions of normal use. Thermo labile pharmaceutical products must not be stored in areas shown by temperature mapping to present a risk.
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Government Gazette Board Notice 50, of 27 February 2015, Section 2.3.5.3(f).
A suitable number of temperature recording instruments that complies with or meets WHO specifications, being at least a logging device, must be installed to record temperatures and to provide temperature and profiles as per the temperature mapping of ...
Government Gazette Board Notice 50, of 27 February 2015, Section 2.3.5.3(k).
The refrigerator, cold room or freezer must be connected to an alarm system and/or warning system in the event of a power failure or if the storage area temperature limits are exceeded.
Government Gazette Board Notice 50, of 27 February 2015, Section 2.3.5.3(l).
Any recording devices/instruments must be calibrated annually against a certificated standard.
Government Gazette Board Notice 50, of 27 February 2015, Section 2.3.5.3(j).
The refrigerator, cold room or freezer must be connected to a standby generator or other emergency power system to ensure uninterrupted power supply in the event of power failure.
Government Gazette Board Notice 50, of 27 February 2015, Section 2.3.5.3(a).
Thermo labile pharmaceutical products must be stored in a storage area, refrigerator or cold room, in a temperature regulated environment as per the information on the manufacturer's product label indicating which temperature must be maintained at ...