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April 2014

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Subject:
From:
Melissa Kirkegaard <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 10 Apr 2014 07:58:33 -0700
Content-Type:
text/plain
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text/plain (74 lines)
Jessica,
We allow pulls to be up to 3 days early without a deviation. We have not had any negative feedback from an agency about the pull time frame of plus or minus 3 days.

Best Regards,

Melissa Kirkegaard
Stability Manager
Kythera Biopharmaceuticals
27200 West Agoura Road
Suite 200
Calabasas, CA 91302

On Apr 8, 2014, at 12:40 PM, Jessica Sloan <[log in to unmask]> wrote:

> 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.
> 
> 
> 
> 
> =================================
> 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.
> 
> 
> 
> <image001.jpg>


=================================
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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