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.