Performance Qualification Protocol for Inline pH Control System in IV Infusions
Document Number: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to demonstrate that the Inline pH Control System used in the production of IV infusions consistently performs within specified limits and meets the acceptance criteria defined in the User Requirements Specification (URS) Annex 11.
Scope
This PQ protocol applies to the Inline pH Control System utilized during the compounding of IV infusions (LVP/SVP – Bags/Bottles) in the production area. The system is critical for maintaining pH accuracy during compounding, directly impacting product quality.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Team: Responsible for operating the Inline pH Control System as per the validated procedures.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the operation of the Inline pH Control System.
- Availability of necessary documentation, including URS and SOPs.
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 that ensures pH accuracy, with alarms for deviations and an audit trail for compliance and traceability.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify pH accuracy under normal operating conditions. | pH readings within ±0.1 of target value. | Calibration records, test results. |
| PQ-02 | Test alarm functionality for pH deviations. | Alarms activate within 2 seconds of deviation. | Alarm logs, system response times. |
| PQ-03 | Review audit trail for data integrity. | No unauthorized changes; all entries time-stamped. | Audit trail report. |
Detailed Test Cases
Test Case PQ-01
Objective: Verify pH accuracy under normal operating conditions.
Procedure: Measure pH of a standard solution using the Inline pH Control System. Compare readings to expected values.
Acceptance Criteria: pH readings must be within ±0.1 of the target value.
Expected Results: Documented pH readings that meet acceptance criteria.
Test Case PQ-02
Objective: Test alarm functionality for pH deviations.
Procedure: Simulate pH deviations and observe alarm activation.
Acceptance Criteria: Alarms must activate within 2 seconds of deviation.
Expected Results: Alarm logs demonstrating timely activation.
Test Case PQ-03
Objective: Review audit trail for data integrity.
Procedure: Access the audit trail and verify that all entries are time-stamped and authorized.
Acceptance Criteria: No unauthorized changes; all entries must be traceable.
Expected Results: Audit trail report confirming compliance.
Deviations
Any deviations from the specified acceptance criteria must be documented and assessed for impact on product quality. A root cause analysis must be conducted, and corrective actions implemented as necessary.
Approvals
All test results must be reviewed and approved by the Quality Assurance team before the Inline pH Control System can be deemed qualified for use in production.