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May 2006

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Subject:
From:
Mick Dawson <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 3 May 2006 17:06:23 -0400
Content-Type:
text/plain
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text/plain (147 lines)
Beth:

Perform the test for interference (enhancement/inhibition test)on three
batches of each product.  This is per the "Guideline on Validation of
the Limulus Amebocyte Lysate test as an End-Product Endotoxin Test for
Human and Animal Parenteral Drugs, Biological Products, and Medical
Devices" US Food and Drug Administration, 1987.  I recommend the same of
other samples too.

Please let me know if you have further questions.

Regards,

Mick

Michael E. Dawson, Ph.D.
Director of Regulatory Affairs
Associates of Cape Cod, Inc.
124 Bernard E. St. Jean Drive
East Falmouth, MA 02536
508-540-3444 x2260  Fax: 508-540-8680

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Derenne, Elizabeth M.
Sent: Wednesday, May 03, 2006 9:08 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] test validations

Thank you Ravi,

What about the endotoxin test for interference (enhancement/inhibition
test) does this have to performed three times to validate the test or
just once per formulation?

Beth Derenne

----------------------------------------------------------------------

Date:    Mon, 1 May 2006 14:14:08 -0500
From:    Ravi Talluri <[log in to unmask]>
Subject: Re: test validations

You do not have to do it three times. B/F test need to =

Derenne,=0D=0A=0D=0AYou do not have to do it three times. B/F test need
to =
be done only once=0D=0Aper product, unless there is a change in the
product=
 formulation or any=0D=0Aother changes to the product. Some companies
recom=
mend you do it every=0D=0Ayear or occasionally, just so you know if your
pr=
oduct is acting=0D=0Adifferent.=0D=0AHope that helps.=0D=0A=0D=0ARavi
Tallu=
ri=0D=0ASr. Scientist, Microbiology=0D=0APPD Inc. 8551 Research
Way=0D=0AMi=
ddleton, WI 53562-3581=0D=0A=20=0D=0APhone: 608-203-4393=0D=0AFax:
608-827-=
8807=0D=0A=20=0D=0A=0D=0A

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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

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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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