Design Qualification Protocol for Inline pH Control System in IV Infusions
Document Number: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Prepared By: [Your Name]
Approved By: [Approver Name]
Objective
The purpose of this Design Qualification (DQ) protocol is to ensure that the Inline pH Control System used in the production of IV Infusions meets the specified requirements and operates as intended.
Scope
This protocol applies to the Inline pH Control System utilized in the production area for adjusting the pH during the compounding of IV Infusions, including both Large Volume Parenterals (LVP) and Small Volume Parenterals (SVP).
Responsibilities
- Validation Team: Execution of the DQ protocol.
- Quality Assurance: Review and approval of the DQ protocol.
- Production Team: Provide support and necessary documentation during testing.
Prerequisites
- Completion of User Requirement Specifications (URS).
- Installation Qualification (IQ) and Operational Qualification (OQ) documentation.
- Availability of all necessary test equipment and materials.
Equipment Description
The Inline pH Control System is designed to monitor and adjust the pH of solutions during the compounding process. It features a control loop with alarms for pH accuracy and maintains an audit trail for data integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify pH control loop functionality. | pH adjustments within ±0.1 pH units. | Test report and calibration certificates. |
| DQ-001-02 | Check alarm triggers for pH deviations. | Alarms activate at specified thresholds. | Alarm log and system alerts. |
| DQ-001-03 | Audit trail verification. | Complete and accurate audit trail maintained. | Audit trail report. |
Detailed Test Cases
Test Case 1: pH Control Loop Functionality
Procedure: Simulate pH changes and verify system response.
Expected Result: System adjusts pH within the acceptance criteria.
Test Case 2: Alarm Functionality
Procedure: Introduce pH deviations and observe alarm activation.
Expected Result: Alarms activate as per defined thresholds.
Test Case 3: Audit Trail Verification
Procedure: Review audit trail logs for completeness and accuracy.
Expected Result: Audit trail should reflect all pH adjustments and alarms.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions should be implemented as necessary.
Approvals
The DQ protocol must be reviewed and approved by the Quality Assurance department prior to execution. All signatures must be documented below:
____________________ [Prepared By]
____________________ [Approved By]
Data Integrity Checks
- Ensure all pH measurements are logged automatically.
- Verify that alarm conditions are recorded in the system log.
- Confirm that audit trails are immutable and time-stamped.