Document ID: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Performance Qualification Protocol for Ophthalmic Sterile Filtration Skid
Objective: To validate the performance of the Ophthalmic Sterile Filtration Skid for sterilizing filtration in the production of sterile eye drops and ointments.
Scope: This protocol applies to the Ophthalmic Sterile Filtration Skid (0.22 µm) used in the production area for sterilizing filtration of ophthalmic products.
Responsibilities:
- Validation Team: Execute the protocol and ensure compliance with acceptance criteria.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide necessary support and documentation during the qualification process.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Operational Qualification (OQ) completed successfully.
- Availability of necessary documentation and equipment.
Equipment Description:
The Ophthalmic Sterile Filtration Skid is designed for sterilizing filtration of ophthalmic products through a 0.22 µm filter. The system is critical for ensuring the integrity and sterility of the final product.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001-01 | Flow Rate Verification | Flow rate meets specified limits. | Flow rate log. |
| PQ-001-02 | DP Integrity Test | Integrity test passes. | Integrity test report. |
| PQ-001-03 | Audit Trail Review | Audit trail shows no discrepancies. | Audit trail log. |
Detailed Test Cases:
- Test Case PQ-001-01: Measure and record the flow rate through the filtration skid under specified conditions. Acceptable range: [insert flow rate range].
- Test Case PQ-001-02: Conduct a DP integrity test using [insert method]. Document results and ensure they meet acceptance criteria.
- Test Case PQ-001-03: Review the audit trail for any anomalies or discrepancies. Ensure compliance with data integrity standards.
Deviations: Any deviations from the protocol must be documented and assessed for impact on the qualification results. A deviation report must be filed and reviewed by the Quality Assurance team.
Approvals:
- Validation Team Lead: ____________________ Date: ___________
- Quality Assurance: ____________________ Date: ___________
- Production Manager: ____________________ Date: ___________
Data Integrity Checks:
- Ensure all data is logged electronically with secure access controls.
- Regular backups of data logs must be performed.
- Audit trails must be reviewed bi-weekly to ensure compliance with data integrity requirements.