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July 2018

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Pharmaceutical Stability Discussion Group <[log in to unmask]>
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Fri, 20 Jul 2018 10:26:10 -0400
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Hi Jessica,

I agree with Tony and will elaborate more on the "gets tricky" part.  It's not unusual these days to see a biologic drug substance manufactured on one continent, frozen, and shipped to another for "finishing and filling" into the primary package by a contractor at a time when they can insert it into their schedule while doing the same for other client companies.  This window of time is usually agreed on in advance with the originator, but glitches and delays can occur to add significant chunks to the timeline.  From there, it may again cross a border (and go through customs a second time) to receive an overwrap that will then go through the sterilization process by a second contract company, still subject to the vagaries of scheduling.  There could be a third stop for additional labeling and being placed in an outer marketing package.  By the time these steps occur, the product may have existed from 3 to 6 months, with lots of shipping and handling, freezing and thawing and turbulence in flight or on bumpy roads before it crosses the threshold of the stability chamber.  This adds to the significance of the Initial testing, and introduces additional questions about what proportion of the product's "stability budget" was expended during this time.  As the formal stability study progresses, this "pre-study" history has to be taken into account as a potential contributor to lower initial results and subsequent OOT/OOS outcomes.  The same can be applied to traditional pharma products when time delay and transportation factors come into play.  Stabilitarians, partnering with their Quality Unit, play a key role in raising awareness about the potential impacts the product may experience before formal studies begin and can work to keep these time and processing delays to a minimum according to the susceptibility of the product.

Best regards,

John O'Neill
Nagano Science USA

-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Mazzeo (R&D), Tony
Sent: Wednesday, July 18, 2018 1:08 PM
To: [log in to unmask]
Subject: Re: [PSDGLIST] Stability Study Initiation Requirements

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.

=================================
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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