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1. Process Design: The commercial process is defined during this stage based on knowledge gained through process development activities.

2. Process Qualification: During this stage, the process design is confirmed as being capable of reproducible commercial manufacturing. Including qualification of the facility, utilities and equipment.

3. Continued Process Verification: Maintenance, continuous verification, and process improvement. On-going assurance that routine production process remains in a state of control. Assessed by collecting and monitoring information during commercialization.

Once established, the equipment qualification status must be maintained through:

• Routine monitoring
• Maintenance
• Calibration procedures and the data should be assessed periodically to determine whether re-qualification should be performed

The process qualification stages covers:

• Design of the facility and qualification of equipment
• Performance qualificatio 
• PPQ protocol

Process Design

Stage 1 output:

• Verification/determination of the limits for the critical process parameters.
• The limits/process boundary have been validated.
• Knowledge of process variable is gained, enabling the establishment of control strategy.