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July 2010

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Subject:
From:
kim huynhba <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Tue, 13 Jul 2010 09:17:39 -0400
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Hello Amy:

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.
Warm regards, 
Kim.


-------------------------------
Kim Huynh-Ba
PHARMALYTIK
[log in to unmask]
www.pharmalytik.com


________________________________
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

Hi,
> 
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?

Thanks,
Amy


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