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July 2010

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Subject:
From:
"Weiss, George" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 23 Jul 2010 07:17:20 -0400
Content-Type:
text/plain
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1.-yes
2. I do not know

George Weiss
Group Leader
QM-QC-chemistry
* 973-235-7027
7  973-235-2915 or 3375 
e-mail: [log in to unmask] 

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-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Teresa I Lucas
Sent: Thursday, May 13, 2010 2:46 PM
To: [log in to unmask]
Subject: [PSDGLIST] Oral Bulk Hold Time Studies

Hi,

1.  After completing oral bulk hold time studies, do you place the packaged
product on stability?

2.  Have any agencies asked if stability studies are run after product is
packaged?

Note:  WHO Technical Report Series 953, Annex 2 states:  "the impact on
stability of the packaged product should be evaluated and studied."

Thank you,

Teresa Lucas
Eli Lilly and Company
Global Stability Coordinator

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Environmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers and
   Provider of Complete Validation & Calibration Services


Calvex, LLC - http://www.calvex.net
   Validation and Calibration Services

Veriteq Instruments - http://www.veriteq.com/
   Environmental Monitoring, Alarming, Reporting & Validation

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

Environmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers and
   Provider of Complete Validation & Calibration Services


Calvex, LLC - http://www.calvex.net
   Validation and Calibration Services

Veriteq Instruments - http://www.veriteq.com/
   Environmental Monitoring, Alarming, Reporting & Validation

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