Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Design Qualification Protocol for RABS/Isolator in Ophthalmics Production
Objective: To establish a protocol for the design qualification of RABS/Isolator equipment used in the aseptic filling of sterile eye drops and ointments.
Scope: This protocol applies to the validation of RABS/Isolator equipment in the production area for ophthalmic products, ensuring compliance with regulatory standards and product specifications.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol.
- Quality Assurance: Ensures compliance with regulatory requirements and reviews documentation.
- Production Team: Provides operational insights and assists in testing.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) completed.
- Operational Qualification (OQ) planned.
Equipment Description:
The RABS/Isolator is designed to provide an aseptic barrier during the filling process of sterile ophthalmic products. It features glove integrity monitoring, leak integrity testing, and VHP cycle logs to ensure a sterile environment.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-01 | Leak Integrity Test | No leaks detected | Test report |
| DQ-001-02 | Glove Integrity Test | 100% integrity | Test report |
| DQ-001-03 | VHP Cycle Log Review | All cycles within specifications | Log records |
Detailed Test Cases:
- Leak Integrity Test: Conduct a vacuum test to ensure no leaks are present in the RABS/Isolator. Document all findings.
- Glove Integrity Test: Perform a pressure decay test on gloves to verify no breaches. Record results in the validation log.
- VHP Cycle Logs: Review the VHP cycle logs for compliance with defined cycle parameters. Document any deviations.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. Root cause analysis should be conducted, and corrective actions must be implemented.
Approvals:
- Prepared by: ______________________
- Reviewed by: ______________________
- Approved by: ______________________
Data Integrity Checks: Ensure all data collected during testing is securely stored and backed up. Implement audit trails for electronic records to maintain data integrity.