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July 2018

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Subject:
From:
"Mazzeo (R&D), Tony" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 18 Jul 2018 17:08:22 +0000
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Hi Jessica,
I am in R&D.  We don't have a requirement.  However if the release data is more than 30 days old, we generally will test a new sample as the initial results for stability trending. That initial testing will be closer to when we put samples in the chambers.
 Normally, that approach will not be a problem for products that degrade very slowly, but for more labile products or products with tight shelf-life specifications it gets tricky if the initial time point is not close to the DOM.
Regards,
Tony

PS: my opinions are my own and not necessarily those of my employer, etc.

Anthony R. Mazzeo, Ph.D.
Senior Principal Scientist
Analytical Strategy and Operations
Product Development Department

Bristol-Myers Squibb Company
1 Squibb Drive
New Brunswick, New Jersey 08903-0191
USA

Ph: 732-227-7044
[log in to unmask]



-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Jessica Sloan
Sent: Wednesday, July 18, 2018 12:19 PM
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

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    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 - https://na01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.iStability.com%2F&amp;data=02%7C01%7Ctony.mazzeo%40BMS.COM%7C52399a762f054d1a921808d5eccacb34%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C1%7C636675278093686741&amp;sdata=AFYn7Q%2BIdCKrqegRbW9QFcY%2BPZUOuS7g3jnTu5cAKKI%3D&amp;reserved=0
   Provides iStability - Web browser based software for stability management,
   reporting, testing/data management, statistical data analysis, and more.

Avista Pharma Solutions - https://na01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.avistapharma.com%2F&amp;data=02%7C01%7Ctony.mazzeo%40BMS.COM%7C52399a762f054d1a921808d5eccacb34%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C1%7C636675278093686741&amp;sdata=AlhDQPIj4iPv6NHMnld0SzUXuXRdepxr7PsLPjg2JJI%3D&amp;reserved=0
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.

BahnsonEnvironmental Specialties - https://na01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.eschambers.com%2F&amp;data=02%7C01%7Ctony.mazzeo%40BMS.COM%7C52399a762f054d1a921808d5eccacb34%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C1%7C636675278093686741&amp;sdata=2SbP4k0588gixYNDiG8UUx%2BGfOP6500%2FS5dzlb7bHUw%3D&amp;reserved=0
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - https://na01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.cszindustrial.com%2F&amp;data=02%7C01%7Ctony.mazzeo%40BMS.COM%7C52399a762f054d1a921808d5eccacb34%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C1%7C636675278093686741&amp;sdata=iKdH5FCrkirKnvco37i3S11rXmOnEPghggscTxLc2ao%3D&amp;reserved=0
    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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=================================
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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