PHASE 1
Concept
Generation
PHASE 2
Proof of
Concept
PHASE 3
Product Design &
Process Development
PHASE 4
Process Installation
& Optimization
PHASE 5
Process Validation &
manufactoring transfer
Objectives:
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:
- Prepare Process Qualification (PQ) protocol
- Train production personnel
- Execute PQ
- Initial product launch
- Transfer product to manufacturing system
Deliverables:
- PQ protocol and test report
- Training records
- Product release
- Manufacturing systems