I am quite new to the CTC adventure.
After reading the second draft of the WHO CTC guideline, now ECTC (I also wen through the first version and the discussion in Langen and Ottawa), several questions came to my mind, and I would be extremely grateful if some of the forum members can help me out with them
1- Now that the rigid time& temperature conditions of the CTC are only one of the extended temperature conditions eligible for re-labelling, can we assume that the stability studies conducted by the manufacturers when deciding the most appropriate VVM type to reflect their product decay (at 5, 25 and 37°C), can be used for a re-labeling purpose with 37°C as a max. threshold temperature?
2- For those of you who followed the CTC initiative from the beginning, what was the scientific ground to choose 40°C as a threshold, rather than 42, 45 or 37 for that matter? In many countries where MSF intervenes & where a CTC approach can have a great impact, ambient temperatures exceed 40°C during the hot season and can be below 37°C during the cold season.
Thank you beforehand for your answers and thoughts.