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May 2006

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 17 May 2006 08:46:39 -0400
Content-Type:
text/plain
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text/plain (140 lines)
Stephen,

Richard Prince wrote a chapter "A Management Primer on Discrepant Results" 
in Microbiology in Pharmaceutical Manufacturing Edited R. Prince PDA/DHI 
2001

It cites the 1998 FDA Guidance for industry investigating 
out-of-specification test results for pharmaceutical production, CDER, 
Rockville, MD


Tony Cundell
Scarsdale, NY





>From: "Desrosiers, Stephen" <[log in to unmask]>
>Reply-To: The Pharmaceutical Microbiology Forum Email List              
><[log in to unmask]>
>To: [log in to unmask]
>Subject: [PMFLIST] Microbiology OOS handling
>Date: Tue, 16 May 2006 17:05:17 -0400
>
>Dear Forum members,
>
>
>
>I am looking for references on Microbiology OOS handling for non sterile
>products (for example MLT).
>
>
>
>I found in the PMF archives, an e-mail from Bob Friedel making a reference
>to the September 1999 issue of the Microbiological Update. Anything more
>recent?
>
>
>
>Best Regards,
>
>
>
>Stephen Desrosiers
>
>EZEM Canada Inc.
>
>
>
>
>
>
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>=================================
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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

ATS Laboratories - http://www.ats-labs.com

Biolog - http://www.biolog.com

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

Dupont Qualicon - http://www.qualicon.com

EMD Chemicals - http://www.emdchemicals.com

EMSL Analytical, Inc. - http://www.emsl.com

Genomic Profiling Systems, Inc. - http://www.genprosys.com

MIDI, Inc. - http://www.midi-inc.com

Millipore - http://www.millipore.com

Pall - http://www.pall.com

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

Raven Biological Labs - http://www.ravenlabs.com

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

=================================
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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