Document Number: OQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approval Date: YYYY-MM-DD
Operational Qualification Protocol for Barcode Scanner in OSD Production
Objective: To verify that the Barcode Scanner operates within specified parameters and meets compliance with regulatory requirements.
Scope: This protocol applies to the Operational Qualification of the Barcode Scanner used in the Production/Dispensing area for identity verification and traceability of solid dosage forms.
Responsibilities:
- Validation Team: Conducts the OQ testing and documentation.
- Quality Assurance: Reviews and approves the OQ protocol and results.
- Production Staff: Operate the Barcode Scanner and assist in testing.
Prerequisites:
- Training on the operation of the Barcode Scanner.
- Completion of Installation Qualification (IQ).
- Availability of necessary documentation (URS, SOPs).
Equipment Description: The Barcode Scanner is a GMP-compliant instrument used for identity verification and traceability in the production of solid dosage forms. It captures scan accuracy data and maintains an audit trail of all operations performed.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify scan accuracy against known standards. | Scan accuracy ≥ 99%. | Calibration report, test results. |
| OQ-002 | Check audit trail functionality. | Audit trail logs all scans with timestamps and user IDs. | Audit trail report. |
Detailed Test Cases:
- Test Case 1: Conduct a series of scans using known barcodes to validate scan accuracy. Document the percentage of successful scans.
- Test Case 2: Perform a test to ensure that every scan is logged in the audit trail with correct timestamps and user IDs.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality and compliance.
Approvals:
- Validation Team Lead: ____________________ Date: __________
- Quality Assurance Manager: ____________________ Date: __________
Data Integrity Checks:
- Verification of barcode format compliance.
- Regular checks of audit trail for completeness and accuracy.