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May 2018

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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, 2 May 2018 15:56:26 -0400
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The USP chapter <61>, <62>, and <71> mention negative controls as
manipulation controls using a placebo like buffer and not in terms of
performance of the media which is addressed in the growth-promotion testing

On Wed, May 2, 2018 at 2:23 PM, Timothy Cser <[log in to unmask]>
wrote:

> Hi Brad. I would say yes you would need additional negative controls for
> each lot being that each lot is completely different and manufactured under
> different conditions.  The negative control will give you confidence any
> growth is not from contaminated media.  I have no regulatory backup but
> since each lot is manufactured under different circumstances and very
> possibly with different raw materials, I lean toward testing a negative
> control if you absolutely must use 2 lots of media.
>
> Tim Cser
>
> MilliporeSigma
>
> MilliporeSigma is a division of Merck KGaA, Darmstadt, Germany
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] On Behalf Of Bradford Booth
> Sent: Tuesday, May 01, 2018 3:52 PM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Negative Control requirements
>
> Thanks, Jon...
>
> I'm really looking to find out of there is a written regulatory
> requirement for a negative control for every lot/batch of media used in an
> assay.
>
> I can find references requiring negative controls, but I can't find
> anything about a requirement for each lot.  In other words, do I need to
> run two negative controls if I used two lots of plates in my assay.
>
>
> Thanks all,
>
> -Brad
>
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors 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.
If your company would be interested in sponsoring this community, please contact [log in to unmask]

Sartorius https://promotions.sartorius.com/real-heroes

Steris - http://www.sterislifesciences.com/

Avista Pharma Solutions  http://www.avistapharma.com

MilliporeSigma  http://www.emdmillipore.com/

Charles River Laboratories - http://www.criver.com/

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

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

Nelson Labs - http://www.nelsonlabs.com

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

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.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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