Planning phase – Preparing a method transfer


“Materials” that need to be handed over

  • SOP(s) of the test instruction(s)
  • Validation reports
  • Product specifications
  • Samples and reference standards that need to be used


Information that needs to be handed over and compiled

  • Quality Agreement / technical contract
  • Intended purpose of methods
  • Details about the product
    • For example light sensitive, adsorption to plastic or else
  • Details about the method performance (--> risk and gap assessment)
    • Specific device / configuration necessary?
  • Responsibilities
  • Scheduling
  • Transfer strategy