Home Forums General Discussion Criteria Used for Reporting a Stability Study Excursion?

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  • John O’Neill
    Participant
    Post count: 21

    I’d like to ask the Stability Community what criteria they use when deciding to report a Stability Excursion (such as temperature)?
    Do you follow Guidance that encourages reporting anything that exceeds 24 hours, or do you have a pre-determined a tier of thresholds based on degrees outside of range (and perhaps time outside of range). Responses here may be the starting point for a discussion at the upcoming PSDG Meeting.

    adam.keisker
    Participant
    Post count: 1

    I have observed both working for different companies. I personally lean toward a tiered approach as obviously the more extreme the excursion, the less time the product can tolerate without an impact. This has been difficult to define however. I am curious what the industry standard is or what other experts have put into place and defended with regulatory agencies.

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