Document Control
Document Number: DQ-PWST-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Purified Water Storage Tank
Meta Description: This document outlines the Design Qualification (DQ) protocol for the Purified Water Storage Tank in Utilities, focusing on critical parameters and acceptance criteria.
Tags: Design Qualification, Equipment Validation, PW Storage Tank, Utilities, Pharmaceutical
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Purified Water (PW) Storage Tank meets the specified requirements for storing purified water, ensuring microbial integrity and temperature control.
Scope
This protocol applies to the Design Qualification of the Purified Water Storage Tank used in the Utilities area for the storage of purified water, which has a direct impact on product quality.
Responsibilities
- Validation Team: Prepare and execute the DQ protocol.
- Quality Assurance: Review and approve the DQ protocol.
- Engineering: Provide technical specifications and support during the qualification process.
Prerequisites
- Completion of User Requirement Specification (URS) for the PW Storage Tank.
- Availability of necessary documentation and design drawings.
- Approval from relevant stakeholders.
Equipment Description
The Purified Water Storage Tank is designed to store purified water for pharmaceutical manufacturing processes. It is constructed from materials that ensure microbial integrity and is equipped with temperature control mechanisms.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify temperature control functionality | Temperature maintained within specified limits | Temperature logs |
| T2 | Microbial integrity testing | No microbial contamination detected | Microbial test results |
Detailed Test Cases
Test Case 1: Verify Temperature Control Functionality
Objective: Ensure that the temperature control system maintains the required temperature for purified water storage.
Procedure: Monitor the temperature of the PW Storage Tank over a 24-hour period.
Expected Result: Temperature remains within the specified range as per URS Annex15.
Test Case 2: Microbial Integrity Testing
Objective: Confirm that the storage tank maintains microbial integrity.
Procedure: Collect water samples from the tank and conduct microbial analysis.
Expected Result: No microbial contamination detected in the samples.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be implemented if critical parameters are not met.
Approvals
All sections of this protocol must be reviewed and approved by the Validation Team, Quality Assurance, and Engineering before execution.