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Thread: Why temperature monitoring is so important for IMP

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  1. #1
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    Why temperature monitoring is so important for IMP

    Dear All,

    Why it is so important to monitor the temperature of IMP? What happen if temperture goes out of range for 2 hours or 1 day.
    I was assuming that temperature monitoring is only important because
    [LIST][*]No stability data[*]IMP is still in stability testing[*]Sponsor might want to see which affected batch have different action

    Does anyone have idea apart from above mentioned points?

  2. #2
    It should be noted that an IMP must have stability data to support the shelf-life of the product as specified in the IMPD submitted as part of the clinical trial application. Temperature monitoring is to ensure the IMP is being kept within the condictions as stated in the clinical trial applciation (unless there is a good reason this is not required during the risk assessment conducted and documented prior to commencing the trial (i.e. it is market product being stored within it's license conditions, as per the same product that is stored for general use).

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