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Thread: Expiry dates

  1. #1
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    Expiry dates

    I received some IMP that had no expiry date on the packaging only on the QP release. Our Trust policy is that every medcine must have an expiry date on it so we are wrtiing it on - what are others doing in this situation???

  2. #2
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    Since an expiration date must be on the IMP label in accordance with Annex 13 and GMP I cannot see how this material can be used in any clinical trial without becoming a GCP violation. The IMP should have been returned to source as not being fit for purpose and not accepted by the site for use in a CT.

  3. #3
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    I have seen some consultation regarding removal of expiry date from the label for those product which are controlled by IVRS system only. The IVRS system will only assign the drug which is in date. So I believe MHRA is aware of this situation. Even recently I received a shipment which has no expiry on the label.

  4. #4
    See associated FAQ on Clinical Trials section of MHRA website:
    http://www.mhra.gov.uk/Howweregulate...s/index.htm#P2

  5. #5
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    The use of IVRS for expiry date handeling worries me if there is none on the box to double check against. There was a large Pharma sponsored trial that has had a serious breach in the last few years due to the fact that the drug was allocated to a patient even though it would expire during the scheduled treatment for the patient. As a pharmacist releasing a drug for use in a human subject - trial or not - and given this issue i have outlined it doesnt sit well with me professionally to give out a drug I cannot check the date of. I cant imagine that a licenesed drug would be given out with no expiry so why should a trial drug?

    MHRA moderator - perhaps this can be fed back to the next consultation that occurs?

  6. #6
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    The ideology behind expiry date not adding onto the IMP label could be that expiry extension or retest date can be extended electronically. But I personally believe that the IMP label should have expiry date, at the end of the day it is electronic system, sometime error may happen where sponsor may be unaware of. At least in such cases the person checking the IMP have no clue whether it is in date or not.

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