In my experience, the total should be equal to or more than 180 days to
avoid RTR, however I am pretty sure there is a standard industry practice
to pull them a week later and test them and not wait too long for the
samples to be tested. As far as as pulling dates on monthly basis there is
no guidance mentioning the same.
Regards,
Deepak Mehta
Regulatory Specialist
Fresenius Kabi USA, LLC
Three Corporate Drive
Lake Zurich, Illinois 60047
T: +1 8475502666
F: +1 8475507120
C: +1 6464311291
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www.fresenius-kabi.us
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From: "EXTERN Pharmaceutical Stability Discussion Group"
<[log in to unmask]>
To: [log in to unmask]
Date: 07/27/2017 07:11 PM
Subject: Re: [PSDGLIST] Pull window for expiry timepoint
If we pull early +/- at the end total should be or the FDA expectations
are 180 + for total exposure.
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [
mailto:[log in to unmask]] On Behalf Of Edel
Fitzmaurice
Sent: Wednesday, July 26, 2017 2:32 PM
To: [log in to unmask]
Subject: Re: [PSDGLIST] Pull window for expiry timepoint
In my experience, all timepoints should not be pulled early Edel
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [
mailto:[log in to unmask]] On Behalf Of Sandford,
Brett
Sent: 24 July 2017 20:38
To: [log in to unmask]
Subject: [PSDGLIST] Pull window for expiry timepoint
Hi,
We're a new manufacturing site, and we're working on setting up our
Stability program. We have a sister site, and while we're trying to align
with them on most processes, we're finding a couple of spots where we want
to change how we do things. Specifically, they have their pull window for
their expiry pull set as +7 days, whereas all the other timepoint pull
windows are set up as +/- 7 days. They're saying that's to prevent any
scrutiny on their final pull potentially being a couple days short of
absolute expiry; however, our group doesn't feel that is necessary, and
complicates things in LIMS. Does the group have any thoughts on which
process would be the best from an audit perspective?
Thanks!
Brett Sandford
Senior QC Analyst - Sample Management & Stability Boulder Manufacturing
Center (BMC) MedImmune | AstraZeneca
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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.
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.,
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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.
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.
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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.
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.
|
