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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:
Fri, 23 Oct 1998 12:57:55 -0700
Content-Type:
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Roger:

Thank you very much to clarify the status.  I am looking forward to reading
the Jan-Febr. 1999 PF.  I went to the USP Open Conference in May this year,
and I am anxious (but patient) to see the progress of that "Decision Tree"
also.  Thank you again.

Katherine Shih

> -----Original Message-----
> From: RD [SMTP:[log in to unmask]]
> Sent: Friday, October 23, 1998 6:48 AM
> To:   [log in to unmask]
> Subject:      [PMFLIST] Re[2]: [PMFLIST] "Microbial Contamination"
> Harmonization
>
>      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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