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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> Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers
> and
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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
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>
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--
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
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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.
|
