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Auditing a manufacturer



  • Anon
    14/03/2019 09:34
    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!
  • GMP Committee response
    15/11/2019 14:08
    It is not uncommon for a sponsor to be a virtual organisation and as well as not having the facilities nor experience to manufacture IMP, they will also not hold the appropriate licence to (QP) certify IMP for use in a clinical trial. While the QP will be responsible for ensuring the product has been made to GMP, meets all defined quality standards and is in accordance with any clinical filing, the sponsor is still ultimately responsible for conduct of the clinical trial. It is therefore prudent that the sponsor assures itself that the process for QP oversight and certification is robust.
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