Document Control
Document Number: OQ-ICM-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Inline Conductivity Meter
Objective: To validate the operational performance of the Inline Conductivity Meter used in the production of IV Infusions to ensure it meets specified requirements.
Scope: This protocol applies to the Inline Conductivity Meter utilized in the production area for monitoring solution conductivity of LVP/SVP bags and bottles.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the OQ protocol and results.
- Production Personnel: Assist in the execution of the tests as needed.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on the use of the Inline Conductivity Meter.
- Availability of all necessary equipment and materials for testing.
Equipment Description:
The Inline Conductivity Meter is a system used to monitor the conductivity of solutions during the production of IV infusions. It provides real-time data essential for ensuring product quality and compliance.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify accuracy of conductivity measurement at specified points. | ±5% of target conductivity values. | Calibration records, measurement logs. |
| OQ-002 | Test alarm functionality for out-of-range conductivity. | Alarm triggers within 5 seconds of out-of-range condition. | Alarm test logs. |
| OQ-003 | Audit trail verification for data integrity. | Complete and accurate audit trail for all measurements. | Audit trail report. |
Detailed Test Cases:
Test Case OQ-001
Objective: Verify accuracy of conductivity measurement.
Procedure: Measure conductivity at three predetermined points using standard solutions.
Acceptance Criteria: Measurements must be within ±5% of target values.
Evidence: Documented calibration records and measurement logs.
Test Case OQ-002
Objective: Validate alarm functionality.
Procedure: Simulate out-of-range conductivity conditions and observe alarm response.
Acceptance Criteria: Alarm must trigger within 5 seconds.
Evidence: Logs of alarm tests conducted.
Test Case OQ-003
Objective: Ensure data integrity through audit trails.
Procedure: Review audit trail for completeness and accuracy of all measurements.
Acceptance Criteria: Audit trail must reflect all data entries accurately.
Evidence: Audit trail report.
Deviations:
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be developed if necessary.
Approvals:
All results must be reviewed and approved by the Quality Assurance team to ensure compliance with regulatory standards.