Document Number: OQ-001
Version: 1.0
Date: 2023-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Operational Qualification Protocol for Coding/Printing Machine in IV Infusions
Objective: To validate the operational performance of the Coding/Printing Machine used for printing batch and expiry information on IV infusion bags and bottles.
Scope: This protocol applies to the Coding/Printing Machine utilized in the Packaging/Primary area for IV Infusion products (LVP/SVP – Bags/Bottles).
Responsibilities:
- Validation Team: Execute the OQ protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Operations: Ensure proper operation of the equipment during testing.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of all necessary equipment and materials.
- Training of personnel on the use of the Coding/Printing Machine.
Equipment Description:
The Coding/Printing Machine (Inkjet/Laser) is designed to print batch and expiry dates on IV infusion bags and bottles. It is critical for ensuring product traceability and compliance with regulatory requirements.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify print quality using a standard print quality verification method. | Print quality meets specifications outlined in URS Annex 11. | Print samples and quality audit report. |
| OQ-02 | Check the audit trail for print jobs executed. | Audit trail must show all print jobs with timestamps. | Audit trail log. |
| OQ-03 | Perform data integrity checks on the print data. | Data integrity checks confirm no discrepancies. | Data integrity report. |
Detailed Test Cases:
- Test Case OQ-01: Execute a print job and visually inspect the output for clarity and completeness. Document any discrepancies.
- Test Case OQ-02: Access the system’s audit trail and verify that all print jobs are recorded with correct timestamps and user IDs.
- Test Case OQ-03: Conduct data integrity checks by comparing printed data against the input data to ensure accuracy.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed if necessary.
Approvals:
- Validation Team Lead: ____________________ Date: ___________
- Quality Assurance Manager: _______________ Date: ___________