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
Initial product launch
Transfer product to manufacturing system
PQ protocol and test report
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