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February 2016

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Subject:
From:
"Watson, Jenny (GE Power)" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 22 Feb 2016 22:43:11 +0000
Content-Type:
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OSD=Oral Solid Dosage

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Tony Cundell
Sent: Saturday, February 20, 2016 9:53 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] water activity

What is OSD - on-screen display, single source definition, etc.

I would refer you to ICH Q6 Decision tree #8 for a decision flow chart.

On Sat, Feb 20, 2016 at 12:10 AM, Ranganathan <[log in to unmask]> wrote:

> Dear forum members,
>
>
>
> In case of OSD facility, based on water activity in the products can 
> we skip the MLT in finished products (every 5th or 10th batch) or 
> every batch we need to test for MLT.
>
>
>
> Kindly give your feedback.
>
>
>
> Regards
>
> Dhanapal Ranganathan
>
> Apex laboratories
>
> Chennai
>
>
>
>
>
>
>
>
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>
> =================================
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>



--
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

------------------
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Veltek Associates, Inc - https://urldefense.proofpoint.com/v2/url?u=http-3A__www.sterile.com&d=CwIBaQ&c=IV_clAzoPDE253xZdHuilRgztyh_RiV3wUrLrDQYWSI&r=zlO0KlgAwVnuLOIrYfR3AeZDZLgWeTzHM5BaiXAwch4&m=ards1Ilbk7P0gVY-UAJ6wMwR_twYGQ9gOqqUmzS1Jew&s=2IYpCWqiSnL5eVZsL-K4h5SIE0N6BOieQarDFHyEYxs&e= 

=================================
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.

Accuratus Lab Services http://www.accuratuslabs.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Analytical Research Labs - http://arlok.com/

Charles River-Endosafe and Accugenix - http://www.criver.com/emd

Microbiologics, Inc. - http://www.microbiologics.com

Steris - http://www.sterislifesciences.com/

Veltek Associates, Inc - http://www.sterile.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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