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
    • API, excipients, IPC, stability or product release
    • Identification, testing for impurities, content (assay)
  • 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
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