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October 2016

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Subject:
From:
"Sharon L. Blaha" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 27 Oct 2016 12:45:52 +0000
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We require QA and RA approval on protocol document changes in our EDMS system.  Deviations are also tracked in an electronic system that would require QA approvals.

We do not incorporate QA approval to changes in the stability software or data entry.  I don't know how we will design our future LIMS system.

sharon

-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Seibel, Mary
Sent: Wednesday, October 26, 2016 4:19 PM
To: [log in to unmask]
Subject: [PSDGLIST] Approval of Stability Amendments and Deviations

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.

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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.

------------------
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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