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August 2015

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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Mon, 3 Aug 2015 16:25:31 -0400
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Tony,
 
It is a randomized, stratified sampling plan when samples are selected at  
random from each of the three strata.
 
Regards,
Stan Alekman
 
Stanley L. Alekman, PhD
Pharmaceutical Consultant
S. L. Alekman Associates Inc.
 
 
In a message dated 8/3/2015 4:18:20 P.M. Eastern Daylight Time,  
[log in to unmask] writes:

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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> 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
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>



-- 
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.


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