This is a brainless request. Does the audit have any concept on the
relationship between temperature and chemical reactions and microbial
growth?
On Fri, Mar 24, 2017 at 8:56 AM, McGrath, John (QA) <[log in to unmask]>
wrote:
> Hi Stabilitarians,
> We have drug product labelled per CRT : "Store at 25°C excursions
> permitted 15°C to 30°C".
> An inspector requested to see our stability data to support 15°C.
> We have stability data at 30°C but not at 15°C.
> Our thermal cycling data (-10°C) has no aging.
>
> Has anyone else faced questions supporting 15°C on product label?
> Based on our 25/60 data, does Mean Kinetic Temperature idea not support
> "excursions 15C to 30C" or is there other guidance?
> Thank You
> John
>
>
>
>
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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.
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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