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January 2014

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Subject:
From:
e-mail brianmatthews <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Mon, 27 Jan 2014 22:39:03 +0000
Content-Type:
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1.


On 27 January 2014 14:31, Laugen, Harald (GE Healthcare) <
[log in to unmask]> wrote:

> Dear All,
>
> I have a query regarding when you would perform the  ICH validation of
> stability indicating methods for both drug substance and drug product.
>
> According to ICH Q1A (R2) the analytical procedures should be fully
> validated and stability indicating. When would you perform the ICH
> validation of your stability indicating methods:
>
> 1.       Before the 0 months sampling point for the primary batches
>
> or
>
> 2.       Before submission, i.e. for the 12 months sampling point (you
> would then risk to re-start you stability study if there was an issue
> during ICH validation)
>
> Thanks for your input here.
>
> Best regards,
> Harald
>
> Harald Laugen
> Manager, Dept. of Stability Studies
> GE Healthcare
>
> =================================
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> specific statements and endorsements of individuals participating in the
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>
> ------------------
> The PSDGList (http://microbiol.org/psdglist.htm) is operated from The
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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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