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March 2019

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Fri, 15 Mar 2019 13:50:44 -0400
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Pharmaceutical Stability Discussion Group <[log in to unmask]>
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Pharmaceutical Stability Discussion Group <[log in to unmask]>
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Megan Hladek <[log in to unmask]>
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In "Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with
Drugs and Biological Products Testing" it states that functional testing of syringe drug/biologic products may be required at submission which includes safety features (safety device) testing. 

I do not see post-marketing stability requirements for mechanical testing of the safety device of syringe products. Does anyone know if there are post-marketing stability requirements for safety device testing? Does anyone include safety device testing in their annual stability program for syringe products?

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

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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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