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March 2013

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Subject:
From:
Sanjay Dwivedi <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Sat, 16 Mar 2013 19:58:11 +0800
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Dear Min,

First three commercial size lots shall be subjected to stability studies and there after 1 lot per year, usually 1st batch of the year

Regards,
Sanjay Dwivedi


----- Original Message -----
From: Min He <[log in to unmask]>
To: [log in to unmask]
Cc: 
Sent: Thursday, 14 March 2013 6:26 AM
Subject: [PSDGLIST] Stability Testing on commercial lots used on post-approval clinical studies

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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