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May 2008

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Subject:
From:
Deni Williams <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 29 May 2008 18:02:05 -0400
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Good afternoon Cindy,

For our stability dept, and to keep our R&D and QC depts compliant and 
happy, we have all of our stability samples testing within 7 working days from 
the day it comes out of a chamber.  For example, if a sample comes out on 
Monday, it would not have to have its analysis completed until the following 
Wednesday.  This is in our SOP.  We are a CRO facility and do work for cGLP 
and cGMP stability testing. We have never had an issue with our stability 
testing procedure.  I would like to comment and state that I have seen other 
cases where depending on when a sample is pulled from the chamber, typically 
anything 3 months or less, has to be analyzed within a week and then 
anything over 3 months, you have 2 weeks to a month to complete analysis.  
If you have any questions regarding my comments, please do not hesitate to 
ask. 

Best Regards,
   
Deni  

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