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  • njrazorback
    Participant
    Post count: 6

    Do you pull samples from chambers early? Specifically commercial stability studies. Do you have a +/- window for sample pulls where you can pull the samples before (i.e. ” – “) before the scheduled pull date? If so, have you ever been questioned during an audit and how did you defend pulling samples early? I’ve seen some protocols in which a >6 months sample pull allows +/- one week.

    Walter Routh
    Moderator
    Post count: 71

    Yes, samples can be pulled with a +/- window, but not at the expiry interval. The process must be very clearly described in a procedure. The key is that it must never be able to appear as if you’re pulling early in order to get favorable results, and an inspector will be inclined toward answering that for themselves that as they’re evaluating your process. The value of doing this is huge as it enables much more efficient test scheduling in the lab, including more opportunity to batch samples. But, there are a lot of logistical issues that need to be ironed out and put in the procedure. For example, the window could be wider for later intervals, but automating that process in your Stability LIIMS could be tricky.

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