PMFLIST Archives

October 2019

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Jeanne Moldenhauer <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 8 Oct 2019 12:48:04 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (107 lines)
Michael

This question is hard to answer.  If it is a specific USP monograph test,
many of the monographs have specific rules about when you can perform the
retest.  If it is an aseptic product with a sterility failure, you cannot
retest until you conclusively prove the failure was due to the laboratory
error. (FDA Aseptic Guidance 2004)

Therefore you need some more detail on the type of process and type of test
to get a meaningful answer.

Jeanne Moldenhauer

On Tue, Oct 8, 2019 at 10:29 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.
>
> ------------------
> 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.
>

------------------
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.

ATOM RSS1 RSS2