Document Number: OQ-ISF-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Inline Sterile Filtration Skid
Objective: To validate the Inline Sterile Filtration Skid to ensure it meets specified requirements for sterilizing filtration prior to filling.
Scope: This protocol applies to the Inline Sterile Filtration Skid used in the production area for sterile powders and lyophilized products.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for providing access to the equipment and necessary operational support.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on equipment operation.
- Availability of all necessary documentation and logs.
Equipment Description:
The Inline Sterile Filtration Skid is designed for sterilizing filtration of products prior to filling, ensuring the removal of microorganisms and particulates. It operates under critical parameters that directly impact product quality.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify Flow Rate | Flow rate within specified range | Flow rate log |
| OQ-002 | Perform DP Integrity Test | DP integrity test passes | Integrity test report |
| OQ-003 | Review Audit Trail Logs | No discrepancies in logs | Audit trail log review |
Detailed Test Cases:
- Test Case OQ-001: Measure the flow rate during operation and ensure it remains within the specified range. Document the results in the flow rate log.
- Test Case OQ-002: Conduct a Differential Pressure (DP) integrity test according to the SOP. Document the results in the integrity test report.
- Test Case OQ-003: Review the audit trail logs for any discrepancies. Ensure all entries are accurate and complete.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented.
Approvals:
__________________________
Validation Team Lead
__________________________
Quality Assurance Manager