Performance Qualification Protocol for Water for Injection System
Document Number: PQ-WFI-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Objective: To validate the Water for Injection (WFI) System to ensure it meets predefined specifications and regulatory requirements for the generation of WFI.
Scope: This protocol applies to the Performance Qualification of the Water for Injection System within the Utilities area, focusing on critical parameters impacting product quality.
Responsibilities:
- Validation Team: Execute and document the PQ protocol.
- Quality Assurance: Review and approve the PQ protocol and results.
- Engineering: Ensure the WFI system is operational and maintained.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary equipment and resources.
- Training of personnel involved in the validation process.
Equipment Description: The Water for Injection System is designed to produce WFI in compliance with USP standards. The system includes pre-treatment, reverse osmosis, and distillation units, ensuring the removal of contaminants.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-WFI-001 | Conductivity Measurement | Conductivity ≤ 1.3 µS/cm | Conductivity log |
| PQ-WFI-002 | TOC Analysis | TOC ≤ 500 ppb | TOC report |
| PQ-WFI-003 | Microbial Testing | No growth in 100 mL sample | Microbial test report |
| PQ-WFI-004 | Temperature Monitoring | Temperature within 20-25°C | Temperature log |
| PQ-WFI-005 | Audit Trail Review | Complete and accurate audit trail | Audit trail report |
Detailed Test Cases:
- Test Case 1: Measure conductivity after system stabilization. Document readings and ensure they meet acceptance criteria.
- Test Case 2: Perform TOC analysis on WFI samples taken post-production. Record results and verify against acceptance criteria.
- Test Case 3: Conduct microbial testing on WFI samples to confirm no contamination. Document all findings.
- Test Case 4: Monitor and log the temperature of the WFI system during operation. Ensure it remains within specified limits.
- Test Case 5: Review the system’s audit trail for completeness and accuracy. Document any discrepancies.
Deviations: Any deviations from the acceptance criteria must be documented and assessed. Justifications for deviations must be provided and approved by Quality Assurance.
Approvals:
- Validation Team Lead: ______________________ Date: ____________
- Quality Assurance: ______________________ Date: ____________
- Engineering: ______________________ Date: ____________
Data Integrity Checks:
- Ensure all data entries are timestamped and user-identified.
- Regular audits of data logs to confirm accuracy and completeness.
- Implement checks for data anomalies or discrepancies.