Current WHO Status

Based on the above outcome, the experts who met during the 40th WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2005 [16] had to take a decision about the WHO position for future stability testing. They were faced with a difficult situation. The WHO Secretariat reminded the WHO Expert Committee members that the WHO guideline had been revised in the light of harmonisation efforts in collaboration with ICH. After extensive discussion, the Committee reached consensus that the WHO stability guidelines be amended to reflect conditions for Zone IV as follows  

It was agreed that each individual Member State within the former Zone IV would need to indicate which of these conditions (Zones IVA or IVB), would be applicable in its territory. This was intended to accommodate the two conditions currently in use [17], 

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