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October 2016

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Subject:
From:
Stan Alekman <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 28 Oct 2016 00:35:41 -0400
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Philip,

You can find discussion of sample orientation for parenterals in the withdrawn FDA Guidance for Industry -  Stability Testing of Drug Substances
and Drug Products, which was issued as a draft in 1998 but later withdrawn in favor of the ICH stability guidances.

The withdrawn guidance has a great deal of detail and was a good discussion of FDA expectations. While the guidance is withdrawn, I believe that much of its content is scientifically valid.

Regards,
Stan


Stan Alekman
Stanley L. Alekman, PhD
Pharmaceutical Consultants
S.L. Alekman Associates Inc.
[log in to unmask]



-----Original Message-----
From: Gray, Philip <[log in to unmask]>
To: PSDGLIST <[log in to unmask]>
Sent: Thu, Oct 27, 2016 10:41 pm
Subject: [PSDGLIST] Commercial Liquid Parenteral/Semi-permeable container Stability Study Requirements

Hello All,

Can someone please provide information on the following questions, and a guidance reference, if possible.

What are the stability study sample orientation expectations (upright/inverted) for liquid parenteral drug products? Are upright and inverted studies expected for the registration batch(es), process validation batches, and on-going annual commitments?

What are the stability study sample orientation expectations (upright/inverted) for liquids stored in semi-permeable container? Are upright and inverted studies expected for the registration batch(es), process validation batches, and on-going annual commitments?


Thank you in advance,
Phil Gray



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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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