Operational Qualification Protocol for Inline pH Control System in IV Infusions
Document Number: OQ-IPC-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared by: [Name]
Approved by: [Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Inline pH Control System operates according to the specified requirements and is suitable for its intended use in adjusting pH during the compounding of IV Infusions.
Scope
This protocol applies to the Inline pH Control System used in the Production area for LVP/SVP IV Infusions. The qualification will ensure that the system meets all critical parameters and acceptance criteria as outlined in the User Requirement Specification (URS) Annex 11.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for ensuring the system is in a qualified state before use.
Prerequisites
- Installation Qualification (IQ) of the Inline pH Control System must be completed.
- All necessary training for personnel on system operation must be completed.
- Relevant documentation must be available, including URS and system manuals.
Equipment Description
The Inline pH Control System is designed to monitor and adjust pH levels during the compounding of IV Infusions. It includes a pH sensor, control loop, alarms for deviation, and an audit trail for data integrity.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-1 | Verify pH accuracy control loop | pH readings within ±0.1 of target value | Calibration report |
| OQ-2 | Check alarm functionality | All alarms trigger at specified thresholds | Alarm test log |
| OQ-3 | Audit trail verification | All changes logged with user ID and timestamp | Audit trail report |
Detailed Test Cases
Test Case OQ-1: Verify pH accuracy control loop
Procedure: Calibrate the pH sensor and run a series of tests to measure pH levels at specified intervals.
Acceptance Criteria: pH readings must be within ±0.1 of the target value.
Evidence Required: Calibration report and raw data logs.
Test Case OQ-2: Check alarm functionality
Procedure: Simulate conditions that would trigger alarms and verify response.
Acceptance Criteria: All alarms must trigger at the specified thresholds.
Evidence Required: Alarm test log documenting the activation of alarms.
Test Case OQ-3: Audit trail verification
Procedure: Review the system’s audit trail for accuracy and completeness.
Acceptance Criteria: All changes must be logged with user ID and timestamp.
Evidence Required: Audit trail report showing all user actions.
Deviations
Any deviations from acceptance criteria must be documented and assessed for impact on product quality and compliance. A corrective action plan must be developed for any identified issues.
Approvals
Prepared by: ___________________
Date: _______________
Approved by: ___________________
Date: _______________
Data Integrity Checks (CSV Required)
- Ensure that the pH sensor data is logged accurately and matches the displayed values.
- Verify that alarm triggers are recorded in the system log and are retrievable.
- Confirm that audit trails are tamper-proof and can be accessed only by authorized personnel.