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June 2010

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Subject:
From:
"Detweiler, Kevin" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 30 Jun 2010 15:59:44 -0700
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I work for a Molecular Diagnostics company in which we manufacture assay
reagents which contain preservatives.  Currently we perform
Antimicrobial Effectiveness testing for our marketed annual monitoring
stability lots.  However, we are exploring the option of eliminating
this testing for stability.  I wanted see what the practice was for
other companies.  Is Antimicrobial Effectiveness Testing required for
all molecular diagnostic assay reagents on stability which contain
preservative?  Has anyone successfully justified not doing this testing,
and if so, what was the justification?  Any thoughts would be greatly
appreciated.
Thanks,

Kevin Detweiler
QC Stability
Gen-Probe Inc

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