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  • 1.  Stability Study Protocol Amendments

    This message was posted by a user wishing to remain anonymous
    Posted 02-Feb-2017 14:53
    This message was posted by a user wishing to remain anonymous

    Our company is in the process of streamlining our Stability Study SOP and the question came up regarding when it is necessary to amend the protocol if  retains are pulled for the following:
    -OOS Investigations
    -Additional time points added
    -Request of the sponsor for use in an alternative protocol
    -Request of the sponsor for additional testing
    -Additional sample is required due to spillage
    I would appreciate any feedback.


  • 2.  RE: Stability Study Protocol Amendments

    Posted 02-Feb-2017 21:58
    Hi,

    Based on the brief desciption you gave, it is much depend on the nature of your medical device / drug. But based on my experience, if you add additional time point on your SOP, it will be great to be aligned with all your study right when your SOP implemented. In that way, you will not need to amend on the past stability protocol that already done and on going study will complied with your new SOP, which in turn, save you a non-compliance (NC) during audit. At the same time, your engineer will not mistaken on the testing required for additional time point samples as it required to captured in report which refered back to the stability protocol.

    Hope my comments helps!

    Regards,

    ------------------------------
    Winson
    Regional Regulatory Affairs Executive
    Singapore
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    Original Message


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