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March 2013

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Subject:
From:
"Ehteshami, Sara" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 7 Mar 2013 11:43:52 -0500
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text/plain
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text/plain (107 lines)
All,

Does anyone have experience with or know of specific guidelines or regulatory requirements for testing in-use, open vial, and on-board stability for IVD/medical device reagents? 

For example, for a IHC reagent that has an intended storage temp of 2-8C, and contains 50 tests, and package insert claims shelf life when stored at 2-8C. The intended use conditions would be to put the reagent on the instrument and once testing is complete, return it to 2-8C, and reuse, etc. 

 Thank you. 

Sara Ehteshami
Manager, Stability & Surveillance


-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Capucao, Jing [MCCUS]
Sent: Wednesday, March 06, 2013 1:07 PM
To: [log in to unmask]
Subject: Re: [PSDGLIST] In-Use testing

Dear Tila,
Here is the link to the EU CPMP guidance on in-use stability:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003475.pdf

What you are proposing may not be aligned with the test design section, which states:

As far as possible the test should be designed to simulate the use of the product in practice taking into consideration the filling volume of the container and any dilution/reconstitution before use. At intervals comparable to those which occur in practice appropriate quantities should be removed by the withdrawal methods normally used and described in the product literature.

Best regards,
Jing Capucao, Ph. D.
R&D Stability Manager
McNeil Consumer Healthcare

-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Balasuriya, Tila
Sent: Wednesday, March 06, 2013 9:20 AM
To: [log in to unmask]
Subject: [PSDGLIST] In-Use testing

Team,

Would anyone have any experience with conducting In-Use stability studies for an oral  liquid formulation  such as a syrup, to indicate how close to the daily dosing you have to mirror the in-use stability study.
For example if the daily dose is 2mls once per day, would it be acceptable to design the In-Use stability study to remove 14mls (1 week's supply)  aliquots from a bottle once a week.

If you are aware of any ICH guidances, or regulatory experiences etc, please let me know Thanks Tila Balasuriya






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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
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Hardy Diagnostics - http://www.HardyDiagnostics.com
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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.

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.

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