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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, 16 May 2018 12:52:22 -0400
Content-Type:
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The inspector is misinformed

On Wed, May 16, 2018 at 7:58 AM, Natalia Ruiz <[log in to unmask]>
wrote:

> Thank you very much for your reply.
> I have had that consideration, but  an inspector invalidated me a
> suitability test because of my frozen culture was maintained for a period
> of time longer than the expiration date of the original strain from which I
> started. His explanation was that my reserve strain, althoug it was viable
> and pure, could have changed in some gene.
>
> -----Mensaje original-----
> De: The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] En nombre de Samir Shah
> Enviado el: martes, 15 de mayo de 2018 15:09
> Para: [log in to unmask]
> Asunto: Re: [PMFLIST] Test microorganisms suitable in the method
> suitability test
>
> Hello,
>
> The 5 transfer rule takes care of spontaneous mutation related changes.
> So, as long as the frozen culture and retrieval of working culture process
> is included in your 5 transfer rule, the results are valid. Many times
> organizations make mistake in calculating number of transfers and create a
> non-compliant situation.
>
> *______________________________________________________________*
> *Samir Shah Ph. D.*
> *Global Microbiology, **Colgate-Palmolive Technology Center, NJ* *Office
> 732.878.7772 / **VOIP 8-101-7772 / **Mobile 732.509.6666*
>
>
>
> On Tue, May 15, 2018 at 9:10 AM, Natalia Ruiz <[log in to unmask]>
> wrote:
>
> > Dear forum members,
> >
> > I have a question about the strains of the Test Microorganisms
> > Suitable for use in the Method Suitability Test.
> >
> > I use the ATCC strains indicated in Table 1 (Chapter 71) to carry out
> > the Method Suitability Test. But from the subcultivation of a ATCC
> > strain, i obtain reserve strains that i keep frozen to keep them for a
> > long period of time. This reserve strains could differ genetically from
> the mother strain?
> > If one of these reserve strain presented some mutation in a gene with
> > respect to the original strain, but meets the same phenotypic
> > characteristics, would my suitability test be invalid?
> >
> > Thank you for your answer.
> >
> > Best regards.
> >
> >
> >
> >
> >
> > Descripción: Descripción: Descripción: LOGO 2Natalia Ruiz
> >
> > Departamento Control de Calidad
> >
> > Calle 2 y 3 – Parque Industrial Gral. Savio – 7601 – Batán
> >
> > Tel/Fx: +54 223 464-2010 |2011| 3170 int. 168
> >
> > E-mail:  <mailto:[log in to unmask]> [log in to unmask]
> >
> >
> >
> >
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> >
> > Charles River Laboratories - http://www.criver.com/
> >
> > Veltek Associates, Inc - http://www.sterile.com
> >
> > Microbiologics, Inc. - http://www.microbiologics.com
> >
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> >
> > BD Diagnostic Systems - http://www.bd.com/ds/
> >
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> >
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> >
> >
> > =================================
> > The nature of this service is to provide a medium for communication.
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>
> ------------------
> 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/
>
>
> =================================
> 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]
>
> 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/
>
>
> =================================
> 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.
>



-- 
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/


=================================
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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