March 2017


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"McGrath, John (QA)" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Fri, 24 Mar 2017 12:56:57 +0000
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Hi Stabilitarians,
We have drug product labelled per CRT : "Store at 25C excursions permitted 15C to 30C".
An inspector requested to see our stability data to support 15C.
We have stability data at 30C but not at 15C.
Our thermal cycling data (-10C) has no aging.

Has anyone else faced questions supporting 15C on product label?
Based on our 25/60 data, does Mean Kinetic Temperature idea not support "excursions 15C to 30C" or is there other guidance?
Thank You

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