Document Control:
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Inline Tablet Metal Detector
Objective: To validate the operational performance of the Inline Tablet Metal Detector to ensure it effectively detects metal contamination in solid dosage forms.
Scope: This protocol applies to the Inline Tablet Metal Detector used in the Production/Compression area for solid dosage forms.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide necessary support and access to the equipment.
Prerequisites:
- Equipment must be installed and calibrated according to manufacturer’s specifications.
- Personnel must be trained on the operation of the equipment.
- All necessary materials and tools must be available for testing.
Equipment Description: The Inline Tablet Metal Detector is designed to detect metal contaminants in solid dosage forms during the production process. It operates continuously to ensure product safety and quality.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Sensitivity Testing | Detector must identify specified metal contaminants at defined sensitivity levels. | Test results log, Calibration certificates |
| OQ-02 | Reject Verification | All metal contaminants must be rejected and logged by the system. | Audit trail report |
| OQ-03 | Audit Trail Review | Audit trail must show all detection and rejection events. | Audit trail report |
Detailed Test Cases:
- Test Case OQ-01: Conduct sensitivity testing with known metal contaminants. Document the detection rate and sensitivity levels achieved.
- Test Case OQ-02: Run a batch of tablets with metal contaminants and verify that the system rejects all contaminated products. Document the rejection rate.
- Test Case OQ-03: Review the system’s audit trail for the past month to ensure all detection and rejection events are logged and retrievable.
Deviations: Any deviations from the protocol must be documented and reviewed. A root cause analysis must be conducted for any failures to meet acceptance criteria.
Approvals:
- Validation Team Lead: ______________________ Date: __________
- Quality Assurance Manager: ______________________ Date: __________
Data Integrity Checks:
- Verify data logging functionality to ensure all detection events are recorded accurately.
- Check that the system’s audit trail is accessible and retains historical data for the required retention period.
- Conduct periodic reviews of data integrity to ensure compliance with URS Annex 11.