Document ID: PQ-WFI-ST-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Reviewer Name]
Approval Date: [Insert Approval Date]
Performance Qualification Protocol for WFI Storage Tank
This document outlines the Performance Qualification (PQ) protocol for the WFI Storage Tank used in the Utilities area for the storage of Water for Injection (WFI).
Objective: To validate the performance of the WFI Storage Tank in maintaining the microbial integrity level of WFI, ensuring compliance with regulatory standards.
Scope: This protocol applies to the WFI Storage Tank utilized in the Utilities area, impacting the direct quality of pharmaceutical products.
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 equipment and ensuring it operates within specified parameters.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- Operational Qualification (OQ) must be completed and approved.
- All personnel involved must be trained on the equipment and validation procedures.
Equipment Description:
The WFI Storage Tank is designed to store Water for Injection at controlled temperatures to ensure microbial integrity. The tank is equipped with temperature monitoring systems to maintain the required conditions.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-WFI-001 | Measure and record the temperature of WFI in the storage tank. | Temperature must be maintained within specified limits as per URS Annex 15. | Temperature log records. |
| PQ-WFI-002 | Conduct microbial integrity testing of WFI. | No microbial growth detected in samples. | Microbial test results. |
Detailed Test Cases:
- Test Case 1: Ensure the temperature of the WFI Storage Tank is logged at regular intervals (e.g., every hour). Compare the logged data against the acceptance criteria.
- Test Case 2: Collect WFI samples from the storage tank and perform microbial testing. Document any findings and ensure results align with acceptance criteria.
Deviations:
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be developed if necessary.
Approvals:
Approval of this PQ protocol and its results is required from the Quality Assurance department prior to implementation.