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October 2019

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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:
Tue, 29 Oct 2019 17:27:43 -0400
Content-Type:
text/plain
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Selena,

GMPs require that the a pharmaceutical product with an OOS result be
subject to retest if the original test after a lab investigation is found
to be invalid.

If a repeat microbial test of a non-sterile drug product is conducted
testing the original sample and a resample of the batch would be considered
the best practices.

Tony

On Tue, Oct 29, 2019 at 5:17 PM Selena Rossi <[log in to unmask]> wrote:

> Hi everyone,
> how do you perform the investigation for an microbiological OOS?
>
> I'm working in non sterile product company and we are revisioning our SOP
> in according MHRA guidance.
> After retest on initial samples (if available) our doubts are on number of
> resamples. 3,6? Statistical decision?
> And when the initial samples are not available (exmple enviromental
> samples) do you perform a new analysis with new sample?
>
> Any suggestion will be appreciated!
> Thanks in advance and have a great day everyone,
> Selena
>
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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]



Science Advisory Board https://www.scienceboard.net/

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

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

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

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

BD Industrial Media - http://www.bd.com/ds/

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

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