Operational Qualification Protocol for WFI Storage Tank
Document Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the WFI Storage Tank operates within specified parameters to ensure microbial integrity in compliance with URS Annex15.
Scope
This protocol applies to the WFI Storage Tank utilized in the Utilities area for the storage of Water for Injection (WFI). It encompasses all operational aspects that affect the quality of the stored WFI.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with regulatory requirements. The Quality Assurance (QA) department will review and approve the protocol and results.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- All necessary utilities (electricity, water supply) must be operational.
- Personnel must be trained in equipment operation and validation procedures.
Equipment Description
The WFI Storage Tank is designed to store Water for Injection at controlled temperatures to maintain microbial integrity. The tank is constructed of stainless steel and equipped with temperature monitoring devices.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Temperature Monitoring | Temp microbial integrity level must be maintained within 20-25°C | Temperature logs |
Detailed Test Cases
Test Case OQ-001-01: Temperature Monitoring
Objective: To ensure that the WFI Storage Tank maintains the specified temperature range to preserve microbial integrity.
Procedure: Monitor and record the temperature of the WFI Storage Tank over a 24-hour period using calibrated temperature sensors.
Acceptance Criteria: The temperature must remain within 20-25°C throughout the monitoring period.
Evidence: Temperature logs must be reviewed and signed by the Validation team.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A deviation report should be generated, detailing the cause and corrective actions taken.
Approvals
This protocol must be approved by the following personnel:
- Validation Manager: ___________________ Date: __________
- Quality Assurance: ___________________ Date: __________