Regulatory Open Forum

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  • 1.  Alternate Primary Packaging

    Posted 22-Jun-2015 10:00


    What type of filing is required for alterante primary packaging (pouch) for transdermal products.

    Thanks


  • 2.  RE: Alternate Primary Packaging

    Posted 23-Jun-2015 20:42
    Hi Zuriash, 

    First of all, I am assuming the current primary packaging is approved? If so, the the Guidance for Industry Changes to an approved NDA or ANDA April 2004 will be useful. The filing would be dependent on what you mean by alternate and if it does not provide the same protection or better protective properties or if it does not affect product quality, PAS or Supplement - changes being effected in 30 days. You might even be able to submit the change in an annual report if the materials are the same and the performance including leachables/extractables is unchanged. 

    Hope this is helpful,

    Dar



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    Darlene Rosario RAC
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
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    Original Message


  • 3.  RE:Alternate Primary Packaging

    Posted 24-Jun-2015 07:46
    Be sure you are conducting stability trials and testing consistent with your current protocols and at ICH conditions suitable for all target market regions with the changed material since many transdermal products are moisture sensitive. The results of a short stability trial will help you determine your filing path. Also, I'm assuming the new packaging supplier has a DMF on file with FDA?

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    Ginger Cantor RAC
    Centaur Consulting LLC, Owner and Principal Consultant
    River Falls WI
    United States
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    Original Message