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October 2016

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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 27 Oct 2016 06:52:39 -0400
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Yes, we require a deviation to any changes to a stability protocol.


Diane E Gaither
Supervisor, QC Stability and Scheduling
Nutrition & Care
Health Care
Quality Control
Phone +1 765 477-4511
Fax +1 765 477-5070
Mobile +1 765 337-1532
E-Mail: [log in to unmask]
Evonik Corporation Tippecanoe Laboratories
TL23
1650 Lilly Road
Lafayette, IN
47909-9201
USA
www.evonik.com




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From:   "Seibel, Mary" <[log in to unmask]>
To:     [log in to unmask], 
Date:   10/26/2016 09:00 PM
Subject:        [PSDGLIST] Approval of Stability Amendments and Deviations
Sent by:        Pharmaceutical Stability Discussion Group 
<[log in to unmask]>



All,

Currently QA approves all amendments and deviations to a formal stability 
protocol. 

I have recently received push back from a LIMS vendor on this point.

I would like to know if other companies require QA approval.

Thanks in advance for your response.

Mary W. Seibel
Procter & Gamble
Section Head
New Chapter Analytical | Global Health Care Compliance & Stability

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Avista Pharma Solutions - http://www.avistapharma.com/
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product 
development and manufacturing.


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

Cincinnati Sub-Zero - http://www.cszindustrial.com/
    Provides a large selection of environmental chambers from benchtop, 
reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling 
applications.



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


Avista Pharma Solutions - http://www.avistapharma.com/
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.


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

Cincinnati Sub-Zero - http://www.cszindustrial.com/
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.

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