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October 1998

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The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Fri, 23 Oct 1998 08:48:07 EST
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     Katherine:
     Chapter <1227> is not in the 9th Supplement of USP 23. It is scheduled
     to be included in Supplement 10. The latest version  proposal was in
     PF, Jan-Febr. 1998, and will be the one in Supplement 10, with  a few
     editorial changes. These editorial changes will appear in the
     Jan-Febr. 1999 PF.

     The recovery scheme apply to quantitative enumeration tests not to
     qualitative. If you are a little more patient we are completing a
     total revamping of the Microbial Limit Tests chapter that will provide
     a procedure for determinuing that your enrichment medium as well as
     your agar is tested for their intended purpose.

            Hope that this answer is helpful.

               Roger Dabbah, USP


______________________________ Reply Separator _________________________________
Subject: Re: [PMFLIST] "Microbial Contamination" Harmonization
Author:  The Pharmaceutical Microbiology Mail List <[log in to unmask]> at
internet-mail
Date:    10/22/98 8:50 PM


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
Oread


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