Document Control Number: IQ-FT-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Filter Integrity Tester
Objective: To establish and document the Installation Qualification (IQ) of the Filter Integrity Tester to ensure it operates as intended and meets regulatory requirements.
Scope: This protocol applies to the Installation Qualification of the Filter Integrity Tester used in the production and quality control of prefilled syringes and cartridges.
Responsibilities:
- Validation Team: Responsible for the execution of the IQ protocol.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
- Maintenance Team: Responsible for ensuring the equipment is maintained according to the manufacturer’s specifications.
Prerequisites:
- Completion of equipment installation as per manufacturer’s guidelines.
- Training of personnel on the operation of the Filter Integrity Tester.
- Availability of all necessary documentation (User Manual, Calibration Certificates, etc.).
Equipment Description: The Filter Integrity Tester is an instrument used to verify the integrity of filters in prefilled syringes and cartridges through bubble point diffusion audit trail logs. This equipment is critical to ensure product safety and compliance with regulatory standards.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation according to manufacturer’s specifications. | Installation completed without deviations. | Installation Report |
| IQ-02 | Check calibration status of the instrument. | Calibration within specified date range. | Calibration Certificate |
| IQ-03 | Review bubble point diffusion audit trail logs. | Logs show no anomalies. | Audit Trail Log Report |
Detailed Test Cases:
- Test Case 1: Confirm all components of the Filter Integrity Tester are present and correctly installed.
- Test Case 2: Validate that the instrument is connected to the correct utilities (power, air supply, etc.).
- Test Case 3: Ensure the user interface functions correctly by performing a test run.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be implemented and re-testing performed as necessary.
Approvals:
- Prepared By: ______________________
- Reviewed By: ______________________
- Approved By: ______________________
Data Integrity Checks: Ensure that all data generated during the testing process is securely stored and backed up. Access to data should be restricted to authorized personnel only, and audit trails must be maintained for all data entries.