Government Gazette Board Notice 50, of 27 February 2015, Section 2.3.5.3(b).
The storage area must be large enough to allow for orderly arrangement of products, to permit air circulation especially between shelving and for proper product rotation. If it is filled to capacity, the effect on temperature distribution must be investigated.
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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(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 ...
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.