Performance Qualification Protocol for Inline Sterile Filtration Skid
Document Number: PQ-ISFS-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Performance Qualification (PQ) protocol is to ensure that the Inline Sterile Filtration Skid operates consistently and reliably within specified parameters to achieve the desired sterility assurance for sterile powders and lyophilized products.
Scope
This protocol applies to the Inline Sterile Filtration Skid used in the production area for sterilizing filtration prior to filling operations. It encompasses all activities related to the validation of the system and its critical parameters.
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 Inline Sterile Filtration Skid during the qualification process.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary materials and equipment for testing.
- Training of personnel on equipment operation and safety protocols.
Equipment Description
The Inline Sterile Filtration Skid is designed for sterilizing filtration of liquids intended for sterile filling processes. It includes a series of filters that remove particulate matter and microorganisms, ensuring product sterility.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Flow Rate Testing | Flow rate must meet specified range as per URS | Flow rate log |
| TP-002 | DP Integrity Testing | Integrity test must pass with no leaks | Integrity test report |
| TP-003 | Audit Trail Review | Audit trail must show no discrepancies | Audit trail log |
Detailed Test Cases
Test Case: Flow Rate Testing
Procedure: Measure the flow rate of the Inline Sterile Filtration Skid under normal operating conditions. Record the flow rate.
Acceptance Criteria: Flow rate must fall within the range specified in the URS.
Evidence: Documented flow rate log.
Test Case: DP Integrity Testing
Procedure: Perform a differential pressure integrity test on the filtration system. Ensure that the system holds pressure without any leaks.
Acceptance Criteria: Integrity test must pass with no leaks detected.
Evidence: Integrity test report.
Test Case: Audit Trail Review
Procedure: Review the audit trail logs generated during the operation of the Inline Sterile Filtration Skid to ensure compliance.
Acceptance Criteria: Audit trail must show no discrepancies or unauthorized changes.
Evidence: Documented audit trail log.
Deviations
Any deviations from the specified procedures or acceptance criteria must be documented and reviewed. Appropriate corrective actions must be taken and recorded.
Approvals
Prepared By: ____________________ Date: ___________
Reviewed By: ____________________ Date: ___________
Approved By: ____________________ Date: ___________
Data Integrity Checks
- Ensure all data logged during testing is timestamped and attributed to the operator.
- Regularly back up electronic data to prevent loss.
- Implement access controls to restrict unauthorized changes to the data.