Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Vial Crimping Machine
Objective: To ensure that the Vial Crimping Machine is qualified for its intended use in sealing vials with aluminum caps, ensuring compliance with regulatory requirements and product specifications.
Scope: This protocol applies to the validation of the Vial Crimping Machine used in the production and packaging of sterile powders and lyophilized products.
Responsibilities:
- Validation Team: Responsible for executing the qualification protocol.
- Quality Assurance: Responsible for reviewing and approving the qualification documentation.
- Production Team: Responsible for operating the equipment during qualification testing.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of all necessary documentation and training for personnel.
- Calibration of the Vial Crimping Machine.
Equipment Description: The Vial Crimping Machine is designed to seal vials with aluminum caps, providing a critical barrier to contamination for sterile products. It operates under controlled conditions to ensure the integrity of the sealed vials.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify crimp force settings | Crimp force within specified range | Crimp force audit trail logs |
| T2 | Conduct diameter audit | Diameter falls within acceptable limits | Diameter measurement logs |
| T3 | Review audit trail logs | Logs show no discrepancies | Audit trail log review report |
Detailed Test Cases:
- Test Case T1:
Procedure: Adjust the crimp force settings and verify using calibrated equipment. Record the crimp force.
Acceptance Criteria: The crimp force must be within the specified range as per URS Annex 11.
Evidence: Documented results and calibration certificates.
- Test Case T2:
Procedure: Measure the diameter of the crimped vial using calipers.
Acceptance Criteria: The diameter must fall within the acceptable limits defined in the specifications.
Evidence: Measurement logs and photographs.
- Test Case T3:
Procedure: Review the audit trail logs generated by the machine.
Acceptance Criteria: No discrepancies or errors should be present in the logs.
Evidence: Audit trail review report.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan must be developed if necessary.
Approvals: This protocol must be reviewed and approved by the Quality Assurance team before execution.