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.