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March 2012

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Subject:
From:
Scott Sutton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 2 Mar 2012 15:42:48 -0500
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Jessica,

If you do not test incoming media for acceptability I think the inspector
could come at you a couple ways.

First of all, you don't really know how the vendor performed growth
promotion on the media (ATCC strains, temperatures, times, etc).   Also,
does their lab meet your internal Quality standards?  Does it follow USP?
Has it been audited and do you have access to the raw data or are you
"taking his word for it"?

Secondly, at least for pharma there is a clear requirement to test all
incoming materials in the GMP (21 CFR 211).  I believe something similar
exists in med device ISO as well - can someone help us out here?   As the
lab is GMP, you will be expected to meet relevant GMP requirements which
include incoming acceptance checks.

Thirdly,  how is the media transported?  If you have controlled condition
transport and can document the conditions, then you might be able to
convince the inspector that the media conditions reflected in the CoA are
still relevant to media Quality as it arrives in your lab.  This document
trail is not common, however.

Finally,  a careful reading of the USP chapters (esp <61>, <62>, <71> and
<1117>) may convince you that it is easier to do the growth promotion than
in running the risk in explaining why you didn't do it exactly according to
the instructions for the relevant test.

As a aside, I personally do not believe there is any practical,
science-based reason to require this level of concern over TSA, TSB, SDA or
SDB.   However, we are in the regulated industries.  I strongly recommend
performing these tests as they are relatively easy and greatly reduce
regulatory exposure.

I have to ask.  It was stated that the micro lab is not capable of doing
media GP.  This is pretty basic.  The lab really can't come up with prepared
cultures (available from a variety of sources), incubators, a lab bench and
media?

Scott

=========
Scott Sutton, Ph.D.
Microbiology Network, Inc.
Consultation and training in contamination control & lab operations 
http://www.microbiol.org
+ 585-594-8273 (office)
+1 585-298-0767 (cell)
[log in to unmask]
Twitter - @microbiologynet


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Jessica Wentzel
Sent: Wednesday, February 29, 2012 3:20 PM
To: [log in to unmask]
Subject: [PMFLIST] Growth Promotion Requirements

I'm looking for some guidance on the USP requirement for growth promotion of
media.  I work for a medical device company (non-sterile
manufacturing) and I use TSA and SDA RODACS and RCS strips for environmental
monitoring.  My lab is very new and I do not have the capability to perform
GP yet.  The vendor of the media performs GP prior to releasing it to
customers.  I have written in to our procedures to confirm that this testing
is passing and we obtain CofA's for all media used.  Is this enough?  Or am
I not in compliance by not performing GP myself?

Thanks!

Jessica

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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

Lonza Rapid Testing Solutions - http://www.lonza.com/rts

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

Pall - http://www.pall.com

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

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

Steris - http://www.sterislifesciences.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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