Document Control:
Document Number: DQ-WFI-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Design Qualification Protocol for WFI Storage Tank
Meta Description: This document outlines the Design Qualification protocol for the WFI Storage Tank used in pharmaceutical utilities, ensuring compliance with industry standards.
Tags: Design Qualification, Equipment Validation, WFI Storage Tank, Utilities
Objective
The objective of this Design Qualification (DQ) protocol is to verify that the WFI Storage Tank is designed, installed, and operates in accordance with the user requirements and regulatory standards, ensuring the integrity of the stored water for injection (WFI).
Scope
This protocol applies to the WFI Storage Tank utilized in the utilities area of the pharmaceutical facility, focusing on its design, installation, and operational performance.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for the installation and maintenance of the WFI Storage Tank.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) completed.
- Relevant standard operating procedures (SOPs) are available and reviewed.
Equipment Description
The WFI Storage Tank is designed to store water for injection, ensuring microbial integrity and maintaining appropriate temperature levels. The critical parameters monitored include:
- Temperature
- Microbial integrity level
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| T1 | Verify temperature monitoring system functionality. | Temperature maintained within specified range (e.g., 20-25°C). | Calibration records and monitoring logs. |
| T2 | Perform microbial integrity testing. | No microbial contamination detected. | Microbial test results. |
Detailed Test Cases
Test Case T1: Temperature Monitoring
Objective: To ensure the temperature monitoring system accurately reflects the temperature of the WFI Storage Tank.
Procedure: Verify the calibration of temperature sensors and review temperature logs for the past month.
Acceptance Criteria: Temperature should be consistently maintained within the specified range of 20-25°C.
Evidence: Calibration certificate and temperature logs.
Test Case T2: Microbial Integrity
Objective: To confirm that the WFI Storage Tank maintains microbial integrity.
Procedure: Conduct microbial testing on water samples taken from the tank.
Acceptance Criteria: No microbial contamination detected in test results.
Evidence: Microbial test results documentation.
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
This protocol requires approval from the following individuals:
- Validation Lead: ____________________ Date: ___________
- Quality Assurance: ____________________ Date: ___________
- Engineering: ____________________ Date: ___________