Objectives:
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.
Activities:
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Prepare Process Qualification (PQ) protocol
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Train production personnel
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Execute PQ
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Initial product launch
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Transfer product to manufacturing systems
Deliverables:
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PQ protocol and test report
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Training records
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Product release
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Manufacturing systems
