Document Control
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Sterile Filtration Skid in IV Infusions
Meta Description: This document outlines the Operational Qualification Protocol for the Sterile Filtration Skid used in the production of IV Infusions, focusing on critical parameters and compliance with regulatory standards.
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Sterile Filtration Skid (LVP) operates within specified parameters and meets the requirements outlined in the User Requirement Specification (URS) Annex1 Annex11.
Scope
This protocol applies to the Sterile Filtration Skid used for sterilizing filtration before filling IV Infusions (LVP/SVP – Bags/Bottles) in the Production area.
Responsibilities
- Validation Team: Responsible for the execution of the OQ protocol and documentation of results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Personnel: Responsible for operating the Sterile Filtration Skid during testing.
Prerequisites
- Completion of Installation Qualification (IQ).
- Availability of all necessary equipment and materials.
- Training of personnel on the operation of the Sterile Filtration Skid.
Equipment Description
The Sterile Filtration Skid is designed for the sterilizing filtration of IV Infusions. It includes the following components:
- Filtration unit with integrity monitoring capabilities.
- Flow and differential pressure (DP) monitoring systems.
- Audit trail functionality for data integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify Flow Rate | Flow rate meets specified range | Flow rate log |
| OQ-02 | Perform DP Integrity Test | DP integrity maintained during operation | DP test report |
| OQ-03 | Audit Trail Review | Audit trail shows complete data integrity | Audit trail log |
Detailed Test Cases
Test Case OQ-01: Verify Flow Rate
Objective: To ensure the Sterile Filtration Skid operates within specified flow rate.
Procedure: Measure the flow rate during operation using calibrated flow meters.
Acceptance Criteria: Flow rate must be within [insert specified range].
Evidence: Documented flow rate log.
Test Case OQ-02: Perform DP Integrity Test
Objective: To verify that the differential pressure integrity is maintained throughout the filtration process.
Procedure: Conduct a differential pressure test before and after filtration.
Acceptance Criteria: Differential pressure must not exceed [insert specified limit].
Evidence: Differential pressure test report.
Test Case OQ-03: Audit Trail Review
Objective: To confirm the integrity of the audit trail data.
Procedure: Review the audit trail logs generated during the operation.
Acceptance Criteria: Audit trail must show no discrepancies or data loss.
Evidence: Audit trail log review report.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A corrective action plan should be developed and implemented if necessary.
Approvals
Prepared By: [Insert Name] Date: [Insert Date]
Approved By: [Insert Name] Date: [Insert Date]