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  • 1.  FDA Stability requirements for storage conditions

    Posted 20-Nov-2020 09:56
    Hi RAPS Community,

    We would like to change the storage conditions of a tablet registered in the US and switch from "20-25 degrees Celsius" to " Store ≤ 30 degrees Celsius". Having a maximum limit only in the labels seems quite unusual in the US, and I would like to know if anyone has experience with the type of stability studies that would be required by the FDA to be able to make such claim in the label? 

    Thank you for your help.

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    Charlene Revel
    Senior Regulatory Scientist
    Cambridge MA
    United States
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  • 2.  RE: FDA Stability requirements for storage conditions

    Posted 20-Nov-2020 12:02
    Edited by Jeffrey Freedman 20-Nov-2020 12:03
    Hi Charlene,

    There is a big difference between 20-25 degrees C and <= 30 degrees C. If the product is labeled as store <= 30 degrees C, that means I could store the product at -80, -20, 2-8, RT, etc.. I'd imagine you'd have to demonstrate that the product's safety/efficacy isn't adversely affected under any of those storage conditions, freeze/thaws, etc., and if that's the case it might be more trouble than it's worth.

    Jeff

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    Jeffrey Freedman
    QA/RA Specialist III
    Lowell MA
    United States
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    Original Message


  • 3.  RE: FDA Stability requirements for storage conditions

    Posted 26-Nov-2020 01:28
    Charlene,

    the label you mention is not uncommon for tablets commercialized in the US. To support such claim, you will need long-term stability data collected under "intermediate conditions" (such as 30 C/75% RH) and short-term data under refrigerated (few weeks) and freezing (few days) conditions, to mimic shipping, etc. No need to generate data at lower T (-80 C). 

    Maurizio

    ------------------------------
    Maurizio Franzini
    Regulatory Affairs CMC, Associate Director
    San Francisco CA
    United States
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    Original Message


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