Document Control Number: DQ-OPH-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Approved by: [Approver Name]
Design Qualification Protocol for Dropper/Tip Insertion Machine in Ophthalmics
Objective: To establish and document the design qualification of the Dropper/Tip Insertion Machine used for the insertion of dropper tips/nozzles in the production of sterile eye drops and eye ointments.
Scope: This protocol applies to the Dropper/Tip Insertion Machine utilized in the production area for ophthalmic products, ensuring compliance with regulatory requirements and internal standards.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Operations: Responsible for providing access to the equipment and supporting the validation activities.
Prerequisites:
- Completion of User Requirements Specification (URS) as per Annex 11.
- Availability of the Dropper/Tip Insertion Machine in the production area.
- Training of personnel involved in validation activities.
Equipment Description: The Dropper/Tip Insertion Machine is designed for the automated insertion of dropper tips/nozzles onto vials containing sterile ophthalmic solutions. The machine ensures precise alignment and insertion with minimal operator intervention.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify insertion force alignment | Insertion force within specified limits | Force measurement logs |
| T2 | Check reject logic functionality | Reject logic activates on misalignment | Test results and logs |
| T3 | Audit trail verification | Audit trail captures all actions | Audit trail report |
Detailed Test Cases:
- Test Case T1: Measure the insertion force during operation to ensure it is within the defined limits as per URS Annex 11. Document all measurements.
- Test Case T2: Simulate misalignment and verify that the reject logic activates correctly, preventing defective products. Document the response time and actions taken.
- Test Case T3: Review the audit trail functionality to confirm that all actions taken by the machine are logged accurately and can be retrieved for review.
Deviations: Any deviations from the acceptance criteria must be documented in the deviation log, including the reason for the deviation and corrective actions taken.
Approvals:
- Prepared by: ______________________
- Reviewed by: ______________________
- Approved by: ______________________
Data Integrity Checks:
- Ensure all data entries are timestamped and linked to operator IDs.
- Regular backups of the machine’s data should be conducted.
- Access to the audit trail should be restricted to authorized personnel only.