Document Control Number: PQ-WS-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Water System (PW/WFI) – Point of Use for LVP
Meta Description: This document outlines the Performance Qualification protocol for the Water System used in LVP compounding, ensuring compliance with regulatory standards.
Tags: Performance Qualification, Equipment Validation, Water System, IV Infusions, Utilities
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Water System (PW/WFI) for point of use in LVP manufacturing meets predefined specifications and operates consistently within the defined critical parameters.
Scope
This protocol applies to the Water System utilized for the preparation of water for compounding and cleaning in place (CIP) processes within the utilities area, impacting the quality of LVP/SVP products directly.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ documentation.
- Engineering: Responsible for maintaining the Water System and ensuring it operates within specifications.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary equipment and materials for testing.
- Training of personnel involved in the PQ process.
Equipment Description
The Water System (PW/WFI) serves as a point of use system for providing purified water for compounding LVP/SVP products. It is equipped with monitoring capabilities for critical parameters, including conductivity, total organic carbon (TOC), microbial limits, and temperature.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Conductivity Test | Conductivity ≤ 1.3 µS/cm | Conductivity Log |
| TP-002 | TOC Analysis | TOC ≤ 500 ppb | TOC Report |
| TP-003 | Microbial Testing | No growth in 100 mL sample | Microbial Test Report |
| TP-004 | Temperature Monitoring | Temperature maintained at 20-25°C | Temperature Log |
Detailed Test Cases
Test Case 1: Conductivity Test
Procedure: Measure the conductivity of the water at the point of use using a calibrated conductivity meter. Record the values and compare them against acceptance criteria.
Acceptance Criteria: Conductivity must be ≤ 1.3 µS/cm.
Evidence: Documented conductivity log.
Test Case 2: TOC Analysis
Procedure: Collect samples of water and analyze using a TOC analyzer. Ensure proper calibration and maintenance of the analyzer.
Acceptance Criteria: TOC must be ≤ 500 ppb.
Evidence: TOC analysis report.
Test Case 3: Microbial Testing
Procedure: Conduct microbial testing by incubating water samples in appropriate growth media.
Acceptance Criteria: No growth in 100 mL sample.
Evidence: Microbial test report.
Test Case 4: Temperature Monitoring
Procedure: Monitor the water temperature continuously and record the data.
Acceptance Criteria: Temperature must be maintained at 20-25°C.
Evidence: Documented temperature log.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. Root cause analysis should be conducted, and corrective actions must be implemented to ensure compliance.
Approvals
Prepared by: ______________________ Date: ___________
Reviewed by: ______________________ Date: ___________
Approved by: ______________________ Date: ___________