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.