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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:
Sun, 20 May 2018 13:01:59 -0400
Content-Type:
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Sally,

Yes companies have justified eliminating microbial testing low risk dosage
forms like compressed tablets.

The  concluding chapter of the book I co-edited with Anthony Fontana ,
written by former FDAer David Hussang discusses a regulators viewpoint.

The book is Cundell, A. M and A Fontana (Editors) Water Activity
Application in the Pharmaceutical Industry Davis Horwood/PDA 2009

Tony

On Sun, May 20, 2018 at 5:18 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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-- 
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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