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October 2016

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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 26 Oct 2016 21:56:33 -0400
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Pharmaceutical Stability Discussion Group <[log in to unmask]>
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Tony Cundell <[log in to unmask]>
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Yes, the protocols are regulatory documents.

On Oct 26, 2016 8:48 PM, "Seibel, Mary" <[log in to unmask]> wrote:

> 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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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.

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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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