Document Control Number: DQ-CT-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Design Qualification Protocol for Cap Tightening Machine in Ophthalmics Production
Objective: To establish a Design Qualification (DQ) protocol for the Cap Tightening Machine used in the production of sterile eye drops and ointments, ensuring compliance with regulatory requirements and product specifications.
Scope: This protocol applies to the Cap Tightening Machine utilized in the production area for capping bottles of sterile ophthalmic products, focusing on the criticality of the equipment and its impact on product quality.
Responsibilities:
- Validation Team: Responsible for the execution of the DQ protocol and documentation of results.
- Quality Assurance: Oversee compliance with validation processes and approval of final documentation.
- Production Team: Ensure the equipment is operated according to the established protocols and procedures.
Prerequisites:
- Completion of User Requirement Specification (URS) for the Cap Tightening Machine.
- Installation Qualification (IQ) must be completed prior to DQ execution.
- Staff training on equipment operation and validation procedures.
Equipment Description:
The Cap Tightening Machine is designed to securely cap bottles of sterile eye drops and ointments. It features adjustable torque settings to ensure proper sealing and prevent contamination. The machine includes an audit trail for reject logic to ensure compliance with critical parameters.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify torque range settings. | Torque range must be within specified limits as per URS Annex 11. | Calibration records and torque test results. |
| DQ-02 | Audit trail verification for reject logic. | Audit trail must log all reject events accurately. | Audit trail report and logs. |
Detailed Test Cases:
- Test Case DQ-01:
- Procedure: Adjust the torque settings to the specified range and conduct a test run.
- Expected Result: The machine should operate within the defined torque limits.
- Actual Result: [To be filled during testing]
- Test Case DQ-02:
- Procedure: Initiate a capping process and intentionally trigger a reject event.
- Expected Result: The audit trail should record the reject event with timestamp and reason.
- Actual Result: [To be filled during testing]
Deviations: Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team for impact assessment and corrective actions.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Quality Assurance Manager: ______________ Date: ___________
- Production Supervisor: __________________ Date: ___________
Data Integrity Checks:
- Ensure all data entries are logged with user IDs and timestamps.
- Regular audits of the audit trail to confirm no data manipulation.
- Backup of all electronic records to prevent data loss.