Design Qualification Protocol for Inline Conductivity Meter in IV Infusions
Document Number: DQ-ICM-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Inline Conductivity Meter used for monitoring solution conductivity in IV Infusions meets the specified requirements and is validated for its intended use in the production area.
Scope
This protocol applies to the Inline Conductivity Meter utilized in the production of IV infusions (LVP/SVP – Bags/Bottles) and covers all aspects of its validation, including installation, operational, and performance qualifications.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Team: Responsible for providing operational support during the validation process.
Prerequisites
- Completion of User Requirements Specification (URS) Annex 11.
- Availability of Inline Conductivity Meter and all necessary accessories.
- Training of personnel on equipment operation and validation procedures.
Equipment Description
The Inline Conductivity Meter is a critical system used in the production area to monitor the conductivity of solutions during the IV infusion manufacturing process. It features accuracy alarms and an audit trail for data integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify installation and calibration of the Inline Conductivity Meter. | Meter installed per manufacturer’s specifications and calibrated to meet defined accuracy. | Calibration certificate and installation report. |
| T2 | Conduct accuracy testing using standard solutions. | Accuracy within ±1% of the specified conductivity value. | Test results and data log. |
| T3 | Test alarm functionality. | Alarms trigger at specified conductivity thresholds. | Alarm test report. |
| T4 | Validate audit trail functionality. | Audit trail logs all critical actions and is retrievable. | Audit trail report. |
Detailed Test Cases
Test Case T1: Installation and Calibration Verification
Procedure: Verify that the Inline Conductivity Meter is installed according to the manufacturer’s specifications. Check calibration status and ensure it meets the required standards.
Expected Outcome: The meter is installed correctly, and calibration is within acceptable limits.
Test Case T2: Accuracy Testing
Procedure: Use standard conductivity solutions to assess the accuracy of the meter. Record the conductivity readings.
Expected Outcome: All readings fall within ±1% of the specified values.
Test Case T3: Alarm Functionality
Procedure: Simulate conditions to trigger alarms and verify that they activate as expected.
Expected Outcome: Alarms function correctly at defined thresholds.
Test Case T4: Audit Trail Validation
Procedure: Review the audit trail to ensure all critical actions are logged and can be retrieved accurately.
Expected Outcome: Audit trail is complete and accessible.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on the validation process. A corrective action plan must be implemented as necessary.
Approvals
Prepared by: ____________________ Date: ___________
Reviewed by: ____________________ Date: ___________
Approved by: ____________________ Date: ___________