The purpose of Phase 6 - Process Validation & Manufacturing Transfer is to complete the validation of the manufacturing process through completion of the Process Qualification (PQ).  Upon release of the product for commercialization, and a demonstrated ability to consistently meet quality and cost standards in manufacturing, the process is fully transferred into an ongoing manufacturing environment.


  • Prepare Process Qualification (PQ) protocol

  • Train production personnel

  • Execute PQ

  • Initial product launch

  • Transfer product to manufacturing systems


  • PQ protocol and test report

  • Training records

  • Product release

  • Manufacturing systems

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