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March 2019

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Subject:
From:
John O'Neill <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Tue, 19 Mar 2019 16:08:17 -0400
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Hi Megan,

Some of the In-Use Guidances include that some of the In-Use testing studies should be performed at the end of shelf life. From a previous life experience; generally, in addition to development data for the mechanical performance of the injector, use testing of the injector is included in the stability protocol, both for submission, and post marketing annual studies.  Recent failures of Epi-Pen function have been in the news and I'm thinking the annual study results would be the first place regulators would look to see if use testing was performed, and if it was, did results show the onset of problems?

Let's see what our sharp Stabilitarians say as well.

John O'Neill
Stability Information Specialist
Nagano Science Ltd.

-----Original Message-----
From: Pharmaceutical Stability Discussion Group <[log in to unmask]> On Behalf Of Megan Hladek
Sent: Monday, March 18, 2019 8:55 AM
To: [log in to unmask]
Subject: [PSDGLIST] Safety Device Testing in Annual Stability Program?

Hello,

I have a question regarding drug product filled in syringes with safety device.

I see in “Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products” that testing mechanical features such as the safety device is required at submission of drugs/biologics.

link: https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM147095.pdf

I can not find any guidances that reference post-marketing requirements for mechanical testing of safety features of injectors.  I would assume that once the functional testing is complete, a company would not have to perform the testing again.

Does anyone include testing of safety devices of prefilled syringes in their annual stability program?  

Thank you!

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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.

------------------
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.

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