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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:
Thu, 24 May 2018 11:54:50 -0400
Content-Type:
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Don I fully support your stated position on the role of water activity.

It is not a substitute for microbial limit testing, as it is not a
recommended release test in place of microbial testing.

Tony

On Wed, May 23, 2018 at 8:05 PM, Don English/SUF/US <[log in to unmask]>
wrote:

> Dear Nilkantha,
>
>
> From my perspective, I would just not rely totally on using water activity
> to justify as a reason in not performing microbial testing or do skip lot
> testing on a non-sterile product formulations.  I know that my opinion is
> in the minority on the subject of water activity for non-sterile product
> formulations.
>
>
> For not conducting microbial testing on a non-sterile product formulation,
> a risk assessment should have been conducted to justify the reasons as to
> why  microbial content testing is not conducted and it be documented.  In
> addition, this risk assessment should look as to whether non-susceptible
> raw ingredients to microbial contamination are used in the formulation,
> type of manufacturing conditions (g. are hot temperatures are used such
> above 65C, tablet compression pressures, are hostile raw ingredients to
> microbial growth present in the formulation) and the level of water that is
> present in the formulation for justification in not performing microbial
> content testing on non-sterile product formulations
>
>
> If I was a regulatory inspector, I would want to see this type of risk
> assessment justification to document as to why a non-sterile product
> formulation is not tested for microbial content.   I would question the
> risk assessment if only water activity was used as a justification for not
> conducting microbial content testing on a non-sterile product formulation.
> In the end, maybe it is best that I'm not a regulatory inspector because I
> expect a lot more science be used in justifying decisions to test or not to
> test.
>
>
> Don
>
>
> ________________________________
> From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]
> MICROBIOLOGYNETWORK.COM> on behalf of Nilkantha Banerjee <
> [log in to unmask]>
> Sent: Sunday, May 20, 2018 12:13 PM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Water Activity for Reduced Micro
>
> Hi you can adopt skip lot testing and reduce testing for non sterile
> Pharmaceutical product, this is accepted by regulatory , guidance given in
> WHO TRS and you should justify best on your product category and historical
> data thanks.
> NILKANTHA BANERJEE
>
> On Sun, May 20, 2018, 9:34 PM Meredith, Sally <[log in to unmask]>
> wrote:
>
> > Dear PMF members
> >
> > Has anyone successfully justified reduced micro testing by supplementing
> > water activity instead of USP<61>/<62> using the guidelines in USP<1112>
> > Application of Water Activity Determination for Nonsterile Pharmaceutical
> > Products?
> >
> > How would auditors and regulators respond to this type of reduced
> testing?
> >
> > Thank you for your feedback!
> >
> > Sally Meredith
> > Scientist III, Quality Control
> > Pharma Services
> > Patheon, part of Thermo Fisher Scientific
> >
> >
> >
> >
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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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