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July 1999

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Subject:
From:
GONZALEZ Maria Dolors <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Fri, 9 Jul 1999 10:35:59 +0200
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     My interpretation is : no increase from the previous timepoint tested.
     In fact, it is the same as in USP where it is said "not less than 2.0
     log reduction from the initial count at 14 days and no increase from
     the 14 days' count at 28 days" or "no increase fom the initial
     calculated count at 14 and 28 days" .In all cases we are referring to
     a previous timepoint tested.


     Dolors Gonzalez
     Almirall Prodesfarma


__________________________ Separador de respuesta ______________________________
Asunto: [PMFLIST]
Autor:  The Pharmaceutical Microbiology Mail List <[log in to unmask]> en
INTERNET
Fecha:    08/07/99 9:13


I would like to hear from the group with regards to interpretation of EP
AET limits.  When the EP call for no increase (NI), do you interpret that as
no increase from the initial inoculum as per USP or no increase from the
previous timepoint tested?  We are currently debating this with our QM
group.

:-):-):-):-):-):-):-):-):-):-):-):-):-)
Thank you
Lucy Lee (Hall Dive Location)
Microbiology Business Associate II
AAI - Microbiology
1206 North 23rd Street
Wilmington NC 28405
Phone: (910) 251-6754           SAME PHONE NUMBER
Fax:     (910) 763-5899         NEW FAX NUMBER AT HALL ST


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