Document Number: DQ-PCS-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approved By: [Name]
Design Qualification Protocol for Cartridge Crimping Machine
Objective: To ensure that the Cartridge Crimping Machine meets the required specifications and performs reliably in the production of prefilled syringes and cartridges.
Scope: This protocol covers the design qualification for the Cartridge Crimping Machine used in the production area, specifically for crimping cartridge seals.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol.
- Production Team: Responsible for ensuring the machine is operated as per the validated procedures.
Prerequisites:
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) completed and approved.
- Operational Qualification (OQ) completed and approved.
Equipment Description:
The Cartridge Crimping Machine is designed to crimp the seals of cartridges utilized in prefilled syringes. It operates with a critical focus on crimp force and diameter to ensure proper sealing and product integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify crimp force settings. | Crimp force must meet specified range as per URS Annex11. | Calibration logs, test records. |
| DQ-02 | Conduct diameter audits. | Diameter must fall within specified limits as per URS Annex11. | Audit trail logs, measurement records. |
| DQ-03 | Review audit trail logs. | All logs must show no discrepancies. | Log review documentation. |
Detailed Test Cases:
- Test Case DQ-01: Measure and verify the crimp force. Ensure the machine is set to the correct force and document the readings.
- Test Case DQ-02: Perform diameter checks on crimped cartridges. Use calibrated tools to ensure compliance and document measurements.
- Test Case DQ-03: Review audit trail logs for any anomalies. Document any findings and ensure corrective actions are taken if needed.
Deviations:
Any deviations from the acceptance criteria must be documented and addressed through a formal deviation report, including justification and corrective actions.
Approvals:
All sections of this protocol must be reviewed and approved by the Quality Assurance team before implementation.
Data Integrity Checks:
- Ensure all electronic data is backed up regularly.
- Implement access controls to prevent unauthorized changes to critical parameters.
- Conduct periodic reviews of audit trails to ensure compliance with data integrity standards.