Documents&Manuals

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Provision of IMP related documents:

  • preparation and review of IMP sections in trial protocols
  • preparation of a full or abbreviated Investigational Medicinal Product Dossier (IMPD)
  • IMP guidance section of Investigator’s Brochure (IB)
  • manufacturing documentation – e.g., Certificate of Compliance,
  • generation of randomization list / unblinding list
  • Code Breaking Cards (CBC) / Randomization Envelopes
  • IMP batch release by QP in accordance with Directive 2001/20/EC
  • QP statements related to imported IMP are prepared based on audits of the manufacturer’s production site(s)

IMP documentation respects the interface between Good Manufacturing.

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