Content of a transfer plan

 

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

  • the purpose and scope of the document
  • the transfer strategy to be used
  • the test methods to be transferred
  • the transfer experiments to be performed and its experimental design
  • the materials, devices and device parameters to be used (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
  • special transport and storage requirements for samples and standards
  • the parameters to be evaluated for each method and the acceptance criteria
  • references if necessary

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.

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