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22nd Jan 2016, 06:39 PM
#4
What sort of SOP are they quoting that prohibits them from providing documented evidence that they have taken appropriate care of somebody else's property?
What happens when the trial master file is audited several years down the track, when their temperature monitoring system has been superseded and they can no longer retrieve historical data?
Speaking from the QP/GMP auditor perspective that sort of response aks me wonder what else they might make difficult to prove?
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