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.