First my apologies if this might seem as a strange question, but if anybody could help me, I would be very happy.
I work for a CQA in a CRO and we are contracted to run a study for a sponsor. The sponsor is inexperienced and has contracted an IMP manufacturer to produce the IMP, to do the labelling, packaging, distribution and QP release. The study is run within the EU.
They have asked us to do a vendor audit there, but is this common to do? Isn’t assessment of GMPs etc. responsibility of the QP and part of the QP release?
Thank you for helping me out!