Operational Qualification Protocol for Sterile Holding Tank in Production
Document Control Number: OQ-SHT-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Operational Qualification (OQ) Protocol is to verify that the Sterile Holding Tank operates within specified parameters and meets the requirements outlined in the User Requirement Specification (URS), Annex 1, and Annex 15.
Scope
This protocol applies to the Sterile Holding Tank used in the production area for holding sterile filtered bulk, impacting the product directly and classified as critical.
Responsibilities
The Validation Team is responsible for executing the OQ protocol, documenting results, and ensuring compliance with regulatory requirements. The Quality Assurance Team will review and approve the protocol and results.
Prerequisites
- Completion of Installation Qualification (IQ) for the Sterile Holding Tank.
- Availability of necessary tools and equipment for testing.
- Access to relevant documentation, including URS, Annex 1, and Annex 15.
Equipment Description
The Sterile Holding Tank is designed to hold sterile filtered bulk material under controlled conditions. It is equipped with pressure monitoring and a PLC for data logging and audit trails, ensuring integrity and compliance with critical parameters.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-01 | Pressure Hold Test | Pressure maintained within specified limits for 30 minutes | Pressure log from PLC |
| OQ-02 | Vent Integrity Test | Vent integrity confirmed with no leaks | Leak test report |
| OQ-03 | PLC Audit Trail Verification | Audit trail shows no discrepancies during operation | Audit trail report |
Detailed Test Cases
Test Case OQ-01: Pressure Hold Test
Procedure: Initiate the pressure hold test by setting the Sterile Holding Tank to the specified pressure level. Monitor and record pressure readings at 5-minute intervals for a total duration of 30 minutes.
Acceptance Criteria: Pressure must not drop below the specified limit during the test duration.
Evidence: Documented pressure readings from the PLC log.
Test Case OQ-02: Vent Integrity Test
Procedure: Perform a leak test on the vent system of the Sterile Holding Tank using a suitable method to confirm integrity.
Acceptance Criteria: No leaks detected during the test.
Evidence: Leak test report detailing the method and results.
Test Case OQ-03: PLC Audit Trail Verification
Procedure: Review the PLC audit trail for the Sterile Holding Tank during the operational period to identify any discrepancies or anomalies.
Acceptance Criteria: The audit trail must show consistent operation with no unauthorized changes or interruptions.
Evidence: Extracted PLC audit trail report.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented to address any identified issues.
Approvals
Prepared By: [Insert Name] Date: [Insert Date]
Reviewed By: [Insert Name] Date: [Insert Date]
Approved By: [Insert Name] Date: [Insert Date]
Data Integrity Checks
As CSV is required, ensure the following data integrity checks are performed:
- Regular backups of PLC data logs.
- Validation of data entry methods to prevent manual errors.
- Periodic review of audit trails for compliance and accuracy.