Document Control
Document Number: DQ-OPH-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Author Name]
Approved By: [Approver Name]
Design Qualification Protocol for Ophthalmic Sterile Filtration Skid
Objective: To ensure that the Ophthalmic Sterile Filtration Skid (0.22 µm) meets the requirements for sterilizing filtration of sterile eye drops and eye ointments.
Scope: This protocol applies to the validation of the Ophthalmic Sterile Filtration Skid used in the production area for the direct impact on product quality.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for providing necessary support and access to the equipment.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) completed.
- Operational Qualification (OQ) completed.
Equipment Description:
The Ophthalmic Sterile Filtration Skid is designed for the sterilizing filtration of ophthalmic products with a filter size of 0.22 µm. It includes features for flow, differential pressure (DP) monitoring, and integrity testing.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-1 | Flow Rate Test | Flow rate within specified limits | Test report |
| DQ-2 | DP Integrity Test | DP integrity maintained | Test report |
| DQ-3 | Audit Trail Review | Complete and accurate audit trail | Audit trail log |
Detailed Test Cases:
- Test ID: DQ-1
- Procedure: Measure the flow rate during operation.
- Acceptance Criteria: Should meet specified limits.
- Evidence: Documented flow rate measurements.
- Test ID: DQ-2
- Procedure: Conduct DP integrity test.
- Acceptance Criteria: Integrity must be maintained.
- Evidence: Test results and documentation.
- Test ID: DQ-3
- Procedure: Review audit trail for completeness.
- Acceptance Criteria: Must be complete and accurate.
- Evidence: Audit trail log documentation.
Deviations: Any deviations from the protocol must be documented and approved by Quality Assurance prior to implementation.
Approvals:
- Prepared By: ______________________
- Approved By: ______________________
Data Integrity Checks: Ensure that all data generated during testing is backed up and securely stored. Access to data must be controlled and logged.