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December 2002


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"Gijsbers, J.M.G. (Johan)" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Thu, 19 Dec 2002 09:35:59 +0100
text/plain (53 lines)
Hello forum,
Does anybody know what the (biochemical) differences are between C.
sporogenes ATCC 11437 vs C. sporogenes ATCC 19404? C. sporogenes ATCC 11437
is described in the JP and the USP for the GPP and validation of the
Sterility test. Ph. Eur. descibes C. sporogenes ATCC 19404 for the GPP and
validation of the Sterility test. Are both methods still harmonized? Is it
OK to use either MO and still be in compliance in the view of  e.g. the FDA?
Best regards,

Johan Gijsbers
Organon N.V.
QA-Microbiological Control Laboratory
Room CQ 2209
Molenstraat 110
PO Box 20
5340 BH Oss
The Netherlands
Tel: +31 (0)412 662865
Fax: +31 (0)412 662525
E-mail: [log in to unmask] <mailto:[log in to unmask]>

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