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April 2014

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Subject:
From:
Jessica Wong <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 10 Apr 2014 09:26:13 -0700
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Hi Jessica,

We used to allow early stability pulls.  However, we removed that practice because my previous manager (after she had attended a stability conference) found that there were companies who were cited by the agency for early pulls.  I do not know the names of those companies.  You can probably search for them through the FDA website.  

Kind Regards,
Jessica Wong
Gilead Sciences
San Dimas, CA

-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Jessica Sloan
Sent: Tuesday, April 08, 2014 12:41 PM
To: [log in to unmask]
Subject: [PSDGLIST] Early Stability Pulls

Hi,

I am interested in getting some feedback regarding industry standards for stability pull dates.  Do companies establish a reasonable  window around target pull dates, allowing for early pulls if need be, or is the overall industry practice to never pull early?  Does anyone have specific examples of any agency feedback regarding early stability pulls?

Kind Regards,

Jessica Sloan

RTP Global Stability
5000 Davis Drive
RTP, NC
[log in to unmask]<mailto:[log in to unmask]>
919.993.6445
[Description: cid:image003.jpg@01CE3180.070954B0]
Care Deeply.  Work Fearlessly.  Change Lives.




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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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