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May 2018

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Subject:
From:
Ali Raza <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 24 May 2018 10:51:57 +0500
Content-Type:
text/plain
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Hi Tony;

Sir, I also agree with Alan's statement but you also on the right way.
But I want to share my experience regarding compressed tablet testing for MLT, compressed tablets and coated finished tablets both show microbial growth within specified limit, also the stability samples are being testing after specified intervals and they also show the microbial growth. We also keep the negative as well as positive controls along with the MLT.

Water activity is important there is not any doubt about that but never forget that some microbes can survive harsh conditions and some cannot, we all don't / cannot able to say that if water activity is low then there is no any microbe present in our product, if it is then why we need to sterile our product in case of sterile dry powder injection, it's water activity is also low and it is antibiotic too.

So, the reduced testing in my opinion should not be followed because the world of microbes is totally dependent on probabilities and for this we should think and understand the theme of microbiology not follow just the theories but follow the ground realities which are the other face of hypothesis...

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Tony Cundell
Sent: Tuesday, May 22, 2018 6:51 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Water Activity for Reduced Micro

Alan you have presented a straw man.

Product attributes like water activity is an important consideration in the risk assessment for the justification for the elimination of a microbial specification not a substitution for the test. Other considerations include the microbiological quality of the pharmaceutical ingredients, the dosage form, the formulation, manufacturing process, GMP compliance, packaging, dosage regime, and the target patient population.

That being said ICH Q6 decision trees 6 and 8 does highlight water activity in deciding to set a microbial specification or not.

Tony

On Tue, May 22, 2018 at 3:36 AM, Alan Whipple <[log in to unmask]>
wrote:

> The water activity test should never be considered as an alternative 
> to the microbial limit test. Water activity bears no relationship to 
> microbial content! Low water activity only gives us assurance that 
> microbial proliferation will not occur (it does not guarantee that 
> microbes are not present).  Water activity is one of many factors that 
> should be considered when justifying reduced testing of pharmaceutical products.
> Other key factors to consider include raw material quality, process 
> risk and controls, and historical testing data. If a holistic review 
> of all these factors shows that the product has a low risk of 
> microbial contamination, then reduced testing can be justified.
>
> I personally see little value in routinely testing the water activity 
> of a tablet or powder.  Such testing should only be applied to 
> products where the water activity has a possibility of exceeding 0.6.  
> Why replace one redundant test with another?
>
>
> Alan Whipple
> Microbiology Director (AS&T)
> Consumer Healthcare
> Global Functions
>
>
>
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] On Behalf Of Jeanne Moldenhauer
> Sent: 21 May 2018 15:41
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Water Activity for Reduced Micro
>
> EXTERNAL
>
> I have several clients where we have implemented water activity in 
> place of micro testing.  In all cases, we put it into the submission.  
> If there was a question from an auditor or investigator, we showed 
> them it in the approved submission.  After that, there were no problems.
>
> Jeanne
>
> On Sun, May 20, 2018 at 11:03 AM 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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> 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/
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> Boston Analytical http://www.bostonanalytical.com/
>
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>
>
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> 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/
>
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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]

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.

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