Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Sterile Filtration Skid in IV Infusions
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Sterile Filtration Skid used for sterilizing filtration before filling IV infusions, ensuring compliance with regulatory standards and product quality.
Scope
This protocol applies to the Sterile Filtration Skid utilized in the production area for the preparation of Large Volume Parenterals (LVP) and Small Volume Parenterals (SVP) in bags and bottles.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ documentation.
- Production Team: Responsible for operating the Sterile Filtration Skid during the PQ process.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary materials and equipment.
- Training of personnel on the use of the Sterile Filtration Skid.
Equipment Description
The Sterile Filtration Skid is a system designed for the sterilizing filtration of IV infusions, ensuring the removal of microorganisms while maintaining product integrity. The skid is equipped with integrity testing capabilities and data logging for audit trails.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Flow Rate Testing | Flow rate within specified limits as per URS | Flow rate logs |
| TP-002 | DP Integrity Testing | Integrity test results pass | Integrity test reports |
| TP-003 | Audit Trail Verification | Complete and accurate audit trail | Audit trail logs |
Detailed Test Cases
Test Case: Flow Rate Testing
Procedure: Measure the flow rate of the system using calibrated flow meters. Compare results against acceptance criteria defined in the URS.
Expected Result: The flow rate should be within the specified limits.
Test Case: DP Integrity Testing
Procedure: Perform a bubble point test to ensure the integrity of the filter. Document results for compliance.
Expected Result: The integrity test should pass, indicating no leaks.
Test Case: Audit Trail Verification
Procedure: Review the data logs for completeness and accuracy. Ensure all critical parameters are logged.
Expected Result: The audit trail should be complete, with no discrepancies.
Deviations
Any deviations from the protocol must be documented and investigated. A deviation report should be generated, detailing the nature of the deviation, impact assessment, and corrective actions taken.
Approvals
Prepared by: _______________________ Date: ___________
Reviewed by: _______________________ Date: ___________
Approved by: _______________________ Date: ___________