Operational Qualification Protocol for the Sterile Filtration Skid
Document Control:
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective: To validate the operational performance of the Sterile Filtration Skid used for filtering sterile bulk solutions in the production of prefilled syringes and cartridges.
Scope: This protocol applies to the Sterile Filtration Skid located in the Production area and is intended for the filtering of sterile bulk solutions. It encompasses the verification of critical parameters and compliance with URS Annex1 Annex11.
Responsibilities:
- Validation Team: Overall execution and documentation of the OQ protocol.
- Quality Assurance: Review and approval of the protocol and results.
- Production Team: Support in executing the test cases and providing necessary data.
Prerequisites: Ensure all equipment is calibrated and maintained. Personnel must be trained in the operation of the Sterile Filtration Skid and familiar with the OQ protocol.
Equipment Description: The Sterile Filtration Skid is a system designed to filter sterile bulk solutions. It incorporates a flow DP integrity audit trail logs to ensure compliance with critical parameters during operation.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify flow rate under normal operating conditions. | Flow rate must be within specified limits. | Flow rate log report. |
| OQ-02 | Conduct DP integrity test. | Integrity test must pass without leaks. | Integrity test report. |
| OQ-03 | Review audit trail logs for accuracy. | Audit trail must show complete and accurate data. | Audit trail log review document. |
Detailed Test Cases:
- Test Case OQ-01: Measure the flow rate of the sterile bulk solution through the filtration skid. Record the flow rate and compare it to the established limits.
- Test Case OQ-02: Perform a DP integrity test by isolating the filtration unit and measuring pressure differentials. Document any failures or leaks.
- Test Case OQ-03: Review the audit trail logs for any discrepancies or missing data points. Ensure all entries are complete and accurate.
Deviations: Any deviations from the expected results must be documented and investigated. A corrective action plan should be developed to address any identified issues.
Approvals:
__________________________
Validation Team Lead
__________________________
Quality Assurance Manager
Data Integrity Checks:
- Ensure all data entries in the audit trail logs are timestamped and attributed to the correct operator.
- Regularly back up data logs to prevent loss of critical information.
- Implement access controls to ensure only authorized personnel can modify data.