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March 2019

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Subject:
From:
Megan Hladek <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Mon, 18 Mar 2019 08:55:27 -0400
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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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