Dear All,
Does anyone have any experience with low humidity excursions during a stability study? There seems to be a lot of information regarding how to proceed if there is a temperature excursion but I can’t seem to find anything regarding humidity excursions. Has anyone justified low humidity excursions for their products while on stability? If so, how did you justify it? And, what data did you use to support this justification? No temperature excursion, just lower humidity.
Thanks,
Stability Manager
|
