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July 2012

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Subject:
From:
"Zamora, Josefina A" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Tue, 17 Jul 2012 22:33:52 +0000
Content-Type:
text/plain
Parts/Attachments:
text/plain (111 lines)
Hello everyone:

Thank you for your responses.  Here are the results:

a)      Date of manufacture (DOM) --> 1 of 17

b)      Date samples are placed into different stability chambers --> 11 of 17, many will add a pull on lot expiry date along with the routine ICH time intervals.

c)       If Other, please explain:  --> 5 of 17 use a combination

               for labeled or licensed storage condition or liquid injectables, uses DOM (A)
               for accelerated or other storage conditions or materials, uses date when samples are placed in stability chambers.
               Generally, combination will result in multiple pull / staggered pull dates for the same lots


Josefina

-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Zamora, Josefina A
Sent: 12. juli 2012 03:00
To: [log in to unmask]
Subject: [PSDGLIST] Stability Study Initiation Date


For your stability program which of the following is your study
initiation date:


a)      Date of manufacture (DOM)

b)      Date samples are placed into different stability chambers

c)       If Other, please explain:


Thanks
Josefina Zamora

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Microbiology Network (http://www.microbiol.org) and supported by our
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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

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

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

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

Environmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers and
   Provider of Complete Validation & Calibration Services
The information transmitted is intended only for the person(s)or entity to which it is addressed and may contain confidential and/or legally privileged material. Delivery of this message to any person other than the intended recipient(s) is not intended in any way to waive privilege or confidentiality. Any review, retransmission, dissemination or other use of , or taking of any action in reliance upon, this information by entities other than the intended recipient is prohibited. If you receive this in error, please contact the sender and delete the material from any computer.

For Translation:

http://www.baxter.com/email_disclaimer

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

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

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

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