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July 2018

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Subject:
From:
Emil Friedman <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Tue, 24 Jul 2018 15:46:56 -0400
Content-Type:
text/plain
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text/plain (231 lines)
If you start the study later you'll wind up with a shorter shelf life.

-------------------------------------------
Emil M Friedman, PhD
880 Salem Ave
Hillside, NJ 07205-3035
908-355-8319 (home phone number)
216-287-0821 (cell)
[log in to unmask]
http://www.statisticalconsulting.org


On Sat, Jul 21, 2018 at 11:12 AM, PSDG <[log in to unmask]> wrote:

> Hello Martin,
>
> 30 days has been an interval the FDA uses a lot.  While it does not appear
> in their documents as a requirement, it has become their "expectation" and
> they apply it in 483's and Warning Letters (particularly for time between
> sample pull and testing) as if it had the weight of a Guidance provision.
> This seems to be a key driver in decisions to use the 30 day standard.  I
> have not heard of manufacturing climate-driven start of study time frames,
> but it does make sense to keep the time between manufacturing and start of
> stability to a minimum if there is concern that the product is
> significantly sensitive to the environment.
>
> Regards,
> John O'Neill
> Nagano Sciences USA
>
> -----Original Message-----
> From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]
> MICROBIOLOGYNETWORK.COM] On Behalf Of Martin Heinrich
> Sent: Friday, July 20, 2018 4:34 PM
> To: [log in to unmask]
> Subject: Re: [PSDGLIST] Stability Study Initiation Requirements
>
> I have read the various responses and 30 days seem to be common. However,
> would there be variable time frames in place for the varying study
> conditions?
>
> Ie: your product is manufactured under ICH Zone I 'like' conditions, you
> have 30 days to start Zone I / Zone II studies, and only 15 days to start
> Zone IVa / IVb studies?
>
> What would feedback be on this scenario?
>
> Regards,
>
> _________________________________________
> Martin Heinrich
> factors group
> D 604 777.4311
>
>
> -----Original Message-----
> From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]
> MICROBIOLOGYNETWORK.COM] On Behalf Of Jessica Sloan
> Sent: Wednesday, July 18, 2018 9:19 AM
> To: [log in to unmask]
> Subject: [PSDGLIST] Stability Study Initiation Requirements
>
> Dear PSDG members,
>
> I am curious what requirement other companies have in place for stability
> study initiation windows?  Is there a requirement to initiate the study
> within a certain time frame after date of manufacture?  Are there examples
> in which the study must be initiated within a certain time frame based on
> the data of initiation of release testing (for studies that utilize release
> data as T=0 results on stability)?  Thank you in advance for your feedback!
>
>
> Kind Regards,
>
> Jessica Sloan
> Scientist I, Product Quality Technical Services
>
> =================================
> 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.
>
>
> Nelson Labs - http://www.nelsonlabs.com
>     Nelson Labs is the industry-leading provider of global lab testing and
> expert consulting services.
>     Nelson Labs performs microbiological and analytical laboratory tests
> across the medical device, pharmaceutical and tissue industries.
>
> ScienTek - http://www.iStability.com/
>    Provides iStability - Web browser based software for stability
> management,
>    reporting, testing/data management, statistical data analysis, and more.
>
> 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.
>
> =================================
> 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.
>
>
> Nelson Labs - http://www.nelsonlabs.com
>     Nelson Labs is the industry-leading provider of global lab testing and
> expert consulting services.
>     Nelson Labs performs microbiological and analytical laboratory tests
> across the medical device, pharmaceutical and tissue industries.
>
> ScienTek - http://www.iStability.com/
>    Provides iStability - Web browser based software for stability
> management,
>    reporting, testing/data management, statistical data analysis, and more.
>
> 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.
>
> =================================
> 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.
>
>
> Nelson Labs - http://www.nelsonlabs.com
>     Nelson Labs is the industry-leading provider of global lab testing and
> expert consulting services.
>     Nelson Labs performs microbiological and analytical laboratory tests
> across the medical device, pharmaceutical and tissue industries.
>
> ScienTek - http://www.iStability.com/
>    Provides iStability - Web browser based software for stability
> management,
>    reporting, testing/data management, statistical data analysis, and more.
>
> 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.
>

=================================
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.


Nelson Labs - http://www.nelsonlabs.com
    Nelson Labs is the industry-leading provider of global lab testing and expert consulting services.
    Nelson Labs performs microbiological and analytical laboratory tests across the medical device, pharmaceutical and tissue industries.

ScienTek - http://www.iStability.com/
   Provides iStability - Web browser based software for stability management,
   reporting, testing/data management, statistical data analysis, and more.

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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