September 2017


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Fernanda Palavecino <[log in to unmask]>
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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Thu, 7 Sep 2017 15:29:47 -0400
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Hello Everyone!!
I have an issue with the fate of accelerated stability study when it fails.
 It isn't necessary to perform the analysis up to six months if the failure occurs within the first 3 months, is it?
It is stated for products stored in refrigerator ( ICH It is considered unnecessary to continue to test a product through 6 months when a significant change has occurred within the first 3 months. ) 
So I am based on the same consideration  for Products intended for storage at 25ºC (long term), in cases that accelerated at 40ºC fails within the first three months (and having the intermediate stability on going). Is it my miscoception?
The only way my assumption is taken into account is that it is written explicitly in a standard or guide, do you know if it there is any regulatory statement on this? 
Many thanks!!!

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