Document Control
Document Number: PQ-PW-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Purified Water Generation System
Objective
The objective of this Performance Qualification (PQ) protocol is to demonstrate that the Purified Water Generation System (PW System) operates consistently and produces purified water that meets predefined specifications and regulatory requirements.
Scope
This protocol applies to the Purified Water Generation System located in the Utilities area. It covers the validation of the system to ensure its capability to generate purified water for direct product impact.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Operations: Responsible for maintaining the PW System in accordance with operational procedures.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary documentation such as User Requirement Specifications (URS), Standard Operating Procedures (SOPs), and maintenance logs.
- Training of personnel on the operation and monitoring of the PW System.
Equipment Description
The Purified Water Generation System is designed to produce purified water through a multi-step filtration and purification process. Key features include:
- Conductivity monitoring
- TOC (Total Organic Carbon) analysis
- Flow rate control
- Temperature and pressure monitoring
- Audit trail capabilities for data integrity
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Measure conductivity during operation | Conductivity < 1.3 µS/cm | Conductivity log report |
| TP-002 | Measure TOC levels | TOC < 500 ppb | TOC analysis report |
| TP-003 | Monitor flow rate | Flow rate within specified range | Flow rate log |
| TP-004 | Check temperature | Temperature within specified range | Temperature log |
| TP-005 | Monitor pressure | Pressure within specified range | Pressure log |
| TP-006 | Review audit trail | Complete and accurate audit trail | Audit trail report |
Detailed Test Cases
Test Case 1: Conductivity Measurement
- Procedure: Operate the PW System and record conductivity at regular intervals.
- Expected Result: Conductivity remains below 1.3 µS/cm throughout the testing period.
Test Case 2: TOC Measurement
- Procedure: Collect samples for TOC analysis after continuous operation for 24 hours.
- Expected Result: TOC levels do not exceed 500 ppb.
Test Case 3: Flow Rate Monitoring
- Procedure: Measure flow rate at various operational points.
- Expected Result: Flow rate remains within specified operational range.
Test Case 4: Temperature Monitoring
- Procedure: Monitor temperature during operation.
- Expected Result: Temperature remains within specified limits.
Test Case 5: Pressure Monitoring
- Procedure: Record pressure readings during operation.
- Expected Result: Pressure remains within acceptable limits.
Test Case 6: Audit Trail Review
- Procedure: Review the audit trail for completeness and accuracy.
- Expected Result: Audit trail is complete and accurately reflects system operations.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A formal deviation report should be initiated and reviewed by the Quality Assurance team.
Approvals
Prepared by: ______________________
Reviewed by: ______________________
Approved by: ______________________
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