Design Qualification Protocol for the Filter Integrity Tester
Document Number: DQ-FT-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Filter Integrity Tester used in the production of prefilled syringes and cartridges meets the specified requirements and is suitable for its intended use.
Scope
This protocol applies to the Filter Integrity Tester utilized in the Production/QC area for verifying filter integrity in the manufacturing process of prefilled syringes and cartridges.
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 providing technical support and equipment specifications.
Prerequisites
- Completion of User Requirement Specification (URS) as per Annex 11.
- Installation Qualification (IQ) completed and approved.
- Personnel trained on the operation of the Filter Integrity Tester.
Equipment Description
The Filter Integrity Tester is an instrument used to verify the integrity of filters used in the production of prefilled syringes and cartridges. It measures the bubble point and provides an audit trail of diffusion logs to ensure compliance with regulatory requirements.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-FT-01 | Verify equipment calibration status. | Calibration within the last 12 months. | Calibration certificate. |
| DQ-FT-02 | Review bubble point diffusion audit trail logs. | Logs show no discrepancies. | Audit trail report. |
Detailed Test Cases
Test Case DQ-FT-01
Verify that the Filter Integrity Tester has been calibrated within the last 12 months. Review the calibration certificate for validity.
Test Case DQ-FT-02
Review the bubble point diffusion audit trail logs. Ensure that there are no discrepancies in the recorded data. Document any findings.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team. A root cause analysis should be performed to determine the impact on product quality.
Approvals
The completed DQ protocol must be reviewed and approved by the following personnel:
- Validation Team Lead: [Insert Name]
- Quality Assurance Manager: [Insert Name]
- Engineering Manager: [Insert Name]
Data Integrity Checks
As CSV is required, the following data integrity checks will be performed:
- Verification of user access controls to ensure only authorized personnel can operate the Filter Integrity Tester.
- Regular backups of audit trail logs to prevent data loss.
- Periodic review of data logs for anomalies.