Document Number: IQ-WFI-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Installation Qualification Protocol for WFI Storage Tank
Objective: To outline the procedures for the Installation Qualification (IQ) of the Water for Injection (WFI) Storage Tank to ensure it meets the required specifications and operates effectively to store WFI.
Scope: This protocol applies to the Installation Qualification of the WFI Storage Tank utilized in the Utilities area for direct product impact. It covers the critical aspects of the equipment’s installation and operational readiness.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
- Maintenance Team: Responsible for ensuring the equipment is maintained and any deviations are addressed.
Prerequisites:
- Completion of Design Qualification (DQ).
- Installation of the WFI Storage Tank as per manufacturer specifications.
- Availability of necessary documentation (URS, SOPs, etc.).
Equipment Description:
The WFI Storage Tank is designed to store Water for Injection, ensuring microbial integrity and temperature control. It is critical for maintaining the quality of WFI used in pharmaceutical manufacturing processes.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation according to specifications. | Installation matches the URS Annex15 requirements. | Installation checklist signed off by validation team. |
| IQ-02 | Check temperature control functionality. | Temperature maintained within specified range. | Temperature log records. |
| IQ-03 | Conduct microbial integrity testing. | No microbial contamination detected. | Microbial testing results report. |
Detailed Test Cases:
- Test ID: IQ-01
- Procedure: Inspect the installation of the WFI Storage Tank.
- Acceptance Criteria: Confirm all components are installed as per specifications.
- Evidence: Signed installation checklist.
- Test ID: IQ-02
- Procedure: Measure and log temperature at various points in the tank.
- Acceptance Criteria: Temperature remains within the acceptable range of [specify range].
- Evidence: Temperature logs and calibration certificates.
- Test ID: IQ-03
- Procedure: Conduct microbial testing of the water stored in the tank.
- Acceptance Criteria: No microbial growth observed in samples.
- Evidence: Microbial testing report from accredited lab.
Deviations: Any deviations from the acceptance criteria must be documented and addressed according to the Change Control procedure.
Approvals:
- Validation Manager: ____________________ Date: ___________
- Quality Assurance: ____________________ Date: ___________