Document ID: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Design Qualification Protocol for Sterile Filtration Skid in IV Infusions
Objective: To establish the Design Qualification (DQ) for the Sterile Filtration Skid used in the production of IV infusions, ensuring it meets the specified requirements and regulatory standards.
Scope: This protocol applies to the Sterile Filtration Skid utilized in the production area for sterilizing filtration before filling of LVP/SVP bags and bottles.
Responsibilities:
- Validation Team: Responsible for the execution and documentation of the DQ protocol.
- Quality Assurance: Ensures compliance with regulatory requirements and reviews the protocol.
- Production Team: Provides necessary support during the validation process.
Prerequisites:
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) must be completed.
- Training of personnel on equipment operation and validation procedures.
Equipment Description:
The Sterile Filtration Skid is a system designed for the sterilizing filtration of IV infusions. It includes a series of filters and monitoring systems to ensure the integrity and sterility of the product. The skid is critical for maintaining product quality and compliance with industry standards.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-01 | Verify Flow Rate | Flow rate within specified limits | Flow rate measurement log |
| DQ-02 | Check Differential Pressure (DP) | DP remains within acceptable range | DP monitoring logs |
| DQ-03 | Integrity Test of Filters | Filters pass integrity test | Integrity test results |
| DQ-04 | Audit Trail Review | Complete audit trail available | Audit trail report |
Detailed Test Cases:
- Test Case DQ-01: Measure the flow rate of the sterile filtration skid during operation. The flow rate must be within the defined limits specified in the URS.
- Test Case DQ-02: Monitor the differential pressure across the filters during operation. The DP should remain within the acceptable range throughout the filtration process.
- Test Case DQ-03: Conduct an integrity test on the filters to ensure they are functioning correctly and maintaining sterility. Document the results of the integrity test.
- Test Case DQ-04: Review the audit trail generated by the system to confirm that all operations are logged and that data integrity is maintained.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A formal deviation report should be generated for any non-conformance.
Approvals:
- Validation Lead: _____________________ Date: ____________
- Quality Assurance: ____________________ Date: ____________
- Production Manager: __________________ Date: ____________
Data Integrity Checks:
- Ensure all data entries are timestamped and linked to user credentials.
- Regular backups of data logs must be performed to prevent loss of information.
- Perform periodic reviews of audit trails to confirm no unauthorized access or changes.