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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, 8 Oct 2019 13:43:30 -0400
Content-Type:
text/plain
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The concept of an OOS result that would be investigated to determine the
validity of the test was first introduced in the Federal Judge Wholin Barr
Laboratories verses the U.S..

The FDA published the 2006 Guidance For Industry Investigating
out-of-specification (OOS) test results for pharmaceutical products.

For cGMP compliance reasons it is ill-advised to retest a sample or
resample from a batch without have a sound reason to invalidate the test.

In some circumstances it useful as part of a follow-up investigation to
retest a product to determine the root cause of the failure but not to
overcome the failing result.

Usually any container from a batch manufactured using a validate process
should be representative of that batch. With microbial testing we must
consider heterogeneity, variability of test results and microbial stability
in the product.

On Tue, Oct 8, 2019 at 11:30 AM Michael Barton <[log in to unmask]>
wrote:

> Hi all,
> what are peoples thoughts on when you can or can not perform a re-test
> following obtaining an Atypical or OOS result for a finished product?
>
> Would you say that a re-analysis/re-test (from the same starting sample(s)
> e.g bottles/sampled material in a container) is for additional information
> only to support a decision or if the result is then within specification it
> can be used as a final result and initial result was incorrect (i think
> that that is not the expeceted, as you are not clearly justifying not using
> teh original result).
>
> I have previously heard that it is reasonable to assume that the filled
> product with any contamination may not be homogenous and therefore you may
> not be able to obtain repetitive results and confirm one way or another?
> however if we do say that contamination within the batch is not
> homogenous, how is it reasonably practical to allow us to take such small
> samples for testing and release on the basis of a satisfactory result  if
> it is understood that some of the batch we dont test could be contaminated
> and possibly OOS?
>
> Do we need to assume that our products are homogeneous?  Any references to
> guidance documents/presentations would be appreciated.
>
> Thanks Mike.
>
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> Science Advisory Board https://www.scienceboard.net/
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> 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/
>
>
> =================================
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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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