Medical Devices

Method Transfer and Validation

Whether your quality control strategy utilizes in-house resources, your contract manufacturer, or a third party analytical testing laboratory, or all of the above, the effort to transfer and validate methods suitable for a commercial product is time consuming and management intensive. We can help! A partial list of analytical projects we have undertaken includes:

  • Development of strategy and approach to streamline method transfer or validation efforts
  • Validation of methods for product release, in-process controls, bioanalytical or biomarker methods, cleaning, and raw materials testing
  • Development, oversight, and review of documents related to the comparability and validation efforts, including:
    • Master Plans
    • Development Lab characterization protocols and reports
    • SOPs, batch records, and related GMP documents
  • Specification development
  • Risk assessments and gap analysis
  • Coordination of method transfer with process scale-up activities
  • Technical investigation of deviations, method failures, and out-of-specification results
  • Writing and review of related CMC sections for global regulatory submissions
  • Master planning, scheduling and tracking of validation efforts
  • Validation of related equipment, computer systems and other automated systems
  • Hands-on assistance during method transfer and validation activities