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May 2011

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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
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Sat, 30 Apr 2011 21:33:39 -0700
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
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Have limited experience. Generally the Chinese auditors prefer that you use their guidelines, organisms etc, and even prefer that the testing is done in China - which may be easiest. I don't have experience with sterility and MLT testing there, but some other micro testing. And you are correct, their guidelines are not harmonized and tend to differ disgnificantly from other guidelines.
 
Kate Ambrus

--- On Wed, 4/27/11, Knutsen, Chris <[log in to unmask]> wrote:


From: Knutsen, Chris <[log in to unmask]>
Subject: [PMFLIST] Chinese Pharmacopeia
To: [log in to unmask]
Date: Wednesday, April 27, 2011, 9:15 AM


I have been reviewing the Chinese Pharmacopeia method for sterility and microbial limits.  There are very significant differences from the USP/EP/JP harmonized sterility testing methods.  Is there anyone on this list who has experience with releasing products in China?  Will the harmonized sterility and MLT methods be accepted?

Thank you for your input



Chris Knutsen, Ph.D.
Associate Director, Microbiology
ABD
Bristol-Myers Squibb Company
1 Squibb Drive
New Brunswick, NJ 08902
Tel : +1-732-227-5375
Fax: +1-732-227-3071
e-mail: [log in to unmask]<mailto:[log in to unmask]>
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The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Biotest - http://www.BiotestUSA.com/micro

MicroBioLogics, Inc. - http://www.microbiologics.com

Millipore - http://www.millipore.com

MODA Technology Partners: now a LONZA company http://lonza.com/moda

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

Veltek Associates, Inc - http://www.sterile.com

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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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