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October 1999

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Subject:
From:
Mark E Claerbout <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Wed, 6 Oct 1999 07:48:28 -0500
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Dear forum members,

I am interested in getting opinions as to the need to perform LAL testing on
dry sterile dosage forms on stability, and whether of not companies are
routinely doing this.  The 1998 FDA draft guidance document on Stability
Testing of Drug Substances and Drug Products indicates it "may" not be
necessary (page 38 of the document), which seems rather ambiguous to me.

thanks in advance for any responses,

Mark Claerbout


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