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August 2015

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 31 Jul 2015 10:26:09 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (83 lines)
I believe pulling samples from the beginning, middle and end is termed a
randomized, stratified sampling plan.

With a drug product subjected to process validation any part of the batch
should be representative of the batch
so a beginning, middle and end sampling plan would be limited to R&D
batches.

On Thu, Jul 30, 2015 at 4:27 PM, Seibel, Mary <[log in to unmask]> wrote:

> All,
>
> I am interested in your sampling approach for stability studies.
>
> 1.  How do you sample for stability studies?  Do you pull at the
> beginning, middle, end of batch or combination of these?
>
> 2.  Do you have a rationale to support your sampling plan?  Is this in an
> SOP or documented in the stability protocol?
>
> Many thanks in advance for your response,
>
> Mary W. Seibel
> Procter & Gamble
>
> =================================
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> ------------------
> The PSDGList (http://microbiol.org/psdglist.htm) is operated from The
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> 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.
>



-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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