Content of a transfer plan


The EU GMP Guideline (chapter 6), the USP <1224>, the WHO Guideline 961, Annex 7 as well as the Aide mémoire AiM 07123101 of the ZLG provide details about the content of a transfer plan. The following point(s) should be described:

  • the purpose and scope of the document
  • the responsibilities of both sites (including designation of the persons responsible for the procedure and execution of the method transfer)
  • the transfer strategy to be used, i.e. the “concrete procedure”
  • the test methods to be transferred
  • the transfer experiments to be performed and its experimental design with appropriate rationale to justify the scope
  • the materials, devices and device parameters to be used with an assessment whether qualification is required and if yes, to what extent (if necessary, in a separate method-specific AMTE transfer protocol)
  • requirements for trainings to be conducted if necessary
  • the samples and reference standards to be used (including number of batches, number of samples)
  • special transport and storage requirements for samples and standards
  • the parameters to be evaluated for each method and the acceptance criteria
  • references if necessary
  • Specifications for storing raw data

A transfer plan can additionally include raw data sheets for a consistent documentation of the results of each site.

Furthermore, the transfer plan should specify timelines and documents that need to be handed over.