Operational Qualification Protocol for the Coding Machine in the Packaging of Sterile Powders and Lyophilized Products
Document Number: OQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approval Date: YYYY-MM-DD
Objective: To validate the operational performance of the Coding Machine used for printing batch and expiry information on sterile powders and lyophilized products.
Scope: This protocol applies to the Coding Machine located in the Packaging area and is intended for the validation of its operational capabilities in compliance with regulatory requirements.
Responsibilities:
- Validation Team: Prepare and execute the OQ protocol.
- Quality Assurance: Review and approve the OQ protocol and results.
- Technical Support: Provide assistance in troubleshooting during testing.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of all necessary documentation and training records.
- Calibration of the Coding Machine is up to date.
Equipment Description: The Coding Machine is designed for printing batch and expiry dates on sterile powders and lyophilized products. It operates in a controlled environment to ensure compliance with cGMP standards.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-A | Verify print quality and legibility. | Print quality must meet specifications outlined in URS Annex11. | Printed samples and audit trail logs. |
| OQ-001-B | Check print accuracy against batch records. | 100% accuracy in printed batch and expiry dates. | Comparison report of printed data to batch records. |
| OQ-001-C | Review audit trail logs for completeness. | Audit trail must show all print activities without gaps. | Audit trail log report. |
Detailed Test Cases:
- Test Case OQ-001-A: Execute a print run and evaluate the print quality. Ensure that all printed information is clear, legible, and conforms to specifications.
- Test Case OQ-001-B: Cross-verify the printed batch and expiry dates against the batch records to confirm accuracy.
- Test Case OQ-001-C: Generate and review the audit trail logs to ensure all print activities are recorded accurately and completely.
Deviations: Any deviations from the acceptance criteria must be documented and addressed in accordance with the deviation management process.
Approvals:
- ____________________ (Validation Team Lead)
- ____________________ (Quality Assurance)
Data Integrity Checks:
- Confirm that all data entries in the audit trail are timestamped and user-identified.
- Ensure that the system is protected against unauthorized access.
- Verify that print jobs are logged with a unique identifier for traceability.