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October 1998

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Subject:
From:
"Shih, Katherine" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 22 Oct 1998 16:20:35 -0700
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Laura:

In the USP Microbiology Update seminar yesterday, we discussed the
requirement of three individual validation tests for Microbial Recovery from
Pharmacopoeia Articles (<1227>.   Some how I can not find this Chapter in
USP Supplement 9.  If it is in the Supplement 9, we will be very busy in the
near future.  Will this requirement applies to all tests, or only to the
quantitative tests such as Total Aerobic Microbial Count and Yeast/Mold
Count?  Since the enrichment tests for the objectionable organisms are only
qualitative, I wonder if they need to be individually validated for three
times.

Thanks.

Katherine Shih
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