Document Number: DQ-CTM-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Design Qualification Protocol for Cap Tightening Machine
Objective: To establish and document the qualifications of the Cap Tightening Machine used in the production of Nasal & Otic Products to ensure compliance with regulatory standards.
Scope: This protocol applies to the Cap Tightening Machine utilized in the Production/Packaging area for securing caps on containers of Nasal & Otic Products, both sterile and non-sterile.
Responsibilities:
- Validation Team: Responsible for executing and documenting the DQ protocol.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for operating the Cap Tightening Machine in accordance with the validated procedures.
Prerequisites:
- Completion of User Requirements Specification (URS) as per Annex 11.
- Installation Qualification (IQ) must be completed prior to DQ execution.
- Training of personnel on the operation of the Cap Tightening Machine.
Equipment Description:
The Cap Tightening Machine is designed to securely attach caps to containers for Nasal & Otic Products. It is equipped with torque reject logic to ensure appropriate cap tightness and maintain product integrity.
Test Plan:
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001 | Verify torque reject logic audit trail logs. | Audit trail logs must show no errors for 100% of caps tightened. | Printout of audit trail logs. |
| DQ-002 | Check calibration of torque settings. | Calibration must be within specified limits as per manufacturer’s guidelines. | Calibration certificates. |
| DQ-003 | Perform a functionality test of the machine. | Machine must operate without malfunctions for 100 cycles. | Test cycle report. |
Detailed Test Cases:
- Test Case DQ-001: Execute the torque reject logic audit trail check. Document any discrepancies and ensure corrective actions are taken.
- Test Case DQ-002: Conduct a calibration validation. Document results and ensure all settings are within acceptable limits.
- Test Case DQ-003: Run the machine for 100 cycles, documenting any operational issues or failures.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team. Corrective actions should be implemented as necessary.
Approvals:
- Prepared By: [Preparer Name]
- Reviewed By: [Reviewer Name]
- Approved By: [Approver Name]
Data Integrity Checks:
- Ensure all audit trail logs are securely stored and tamper-proof.
- Regular reviews of logs for any unauthorized access attempts.
- Backup of critical data to prevent loss.