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What are the 4 main elements required to achieve compliance with new storage requirements?
Appropriate equipment. Annual temperature mapping study of all storage areas (cold chain). Annual calibration of all temperature sampling equipment. Data storage, alarming, notifications, compliance reporting, staff training, quality management SOP’s ...
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(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 ...
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 ...
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 ...