You received several good suggestions, I just want to add a few more considerations. Make sure you don't have an outstanding commitment of a stability protocol before making this change, then it'd be either CBE-30 or prior approval depending on the commitment. For commercial, testing product at intended storage condition annually would be sufficient, but you'd need to make sure you have at least 4 data points to perform data analysis. If you have a lot of packages and strengths, you might want to consider matrixing or bracketing to support your annual product monitoring program.
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From: "Cheung, Amy Y" [log in to unmask]>
To: [log in to unmask]
Sent: Tue, July 6> , 2010 11:52:16 AM
Subject: [PSDGLIST] Time point reduction
I would like to know if any company has performed time point reduction>
for post-approval annual commercial stability. If there is, which time>
points were skipped?
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