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March 2013

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 15 Mar 2013 21:48:18 -0400
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One batch representative of each strength and packaging style.

The ongoing stability data should be sufficient

Tony Cundell
Scarsdale, NY

On Wed, Mar 13, 2013 at 8:56 PM, Min He <[log in to unmask]> wrote:

> Hi there,
>
> I would like to seek your opinion/advice on the stability studies on
> commercial lots that will be used for post-approval clinical studies.
> Is it required that those lots be put into stability studies?  Or the
> stability data from an annual batch lot sufficient since they are
> manufactured in  the same way?
>
> Also, only one annual batch is required to be placed in stability
> program per FDA. But there is no requirement on which lot should be. I
> would appreciate if you could share with your experience on this. Do
> you usually put your first commercial lot into stabiilty program as
> your annual batch?
>
> Thanks,
> Min
>
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> BahnsonEnvironmental Specialties - http://www.eschambers.com/
>    Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers
> and
>    Ultra Low Storage Chambers with Complete Validation, Maintenance &
> Calibration
>
> Stability Environments, Inc., an affiliate of Solar Light Company, Inc. -
> http://www.StabilityEnvironments.com
>    High quality controlled environmental walk-in rooms and reach-in
> chambers
>    Full installation, validation and spare parts also available
>
> Hardy Diagnostics - http://www.HardyDiagnostics.com
>     Provides a complete selection of laboratory and microbiology supplies
>     for the clinical, industrial, and molecular biology research
> communities.
>

=================================
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 PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) 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.

BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

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