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  • Thea van der Zande
    Participant
    September 1, 2025 at 8:09 am
    Post count: 1
    #26546

    Does anyone know of specific regulatory guidance that outlines the testing frequency for ongoing stability studies?
    I’m trying to confirm whether the time points 0, 12, 24, and 36 months are officially recommended/accepted, but I haven’t been able to locate a source that explicitly mentions this schedule.

    Mahabub
    Participant
    April 30, 2026 at 1:38 am
    Post count: 1
    #27018

    Annex 10 “Stability testing of active pharmaceutical ingredients and finished pharmaceutical products” Section 2.2.13 it is sated that “testing frequency (generally at 6 months and annual time points is sufficient for ongoing studies)”

    John O’Neill
    Moderator
    October 26, 2026 at 4:13 pm
    Post count: 91
    #27296

    Good question that deserves a concrete answer like the Annex 10 citation above, but an on-line search reveals quite an assortment of variations by professional sources; some include first year testing at every 3 months and others omit any testing below the 12 month point. We sometimes discover widespread industry variances in practice apart from an official guidance. It would make a good poll question for the PSDG. We’ll watch for an opportunity to ask it as well its sequel- “Have you ever been challenged for your ongoing stability protocol, and why?”

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