Installation Qualification Protocol for Inline Tablet Metal Detector
Document Number: IQ-OSD-TMD-001
Version: 1.0
Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Inline Tablet Metal Detector is installed according to the manufacturer’s specifications and is functioning properly to detect metal contamination in solid dosage forms.
Scope
This protocol applies to the installation and qualification of the Inline Tablet Metal Detector used in the Production/Compression area for detecting metal contamination in solid dosage forms. The impact on product quality is considered direct and critical.
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
- Maintenance Team: Responsible for ensuring equipment is maintained and operational.
Prerequisites
- Completion of equipment installation by the vendor.
- Availability of relevant documentation including URS, equipment manual, and maintenance logs.
- Training of personnel on equipment operation and safety protocols.
Equipment Description
The Inline Tablet Metal Detector is designed to detect metal contaminants during the tablet production process. It features advanced sensitivity settings and an audit trail for reject verification.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-TMD-01 | Verify equipment installation according to manufacturer specifications. | All components installed as per specifications. | Installation checklist signed off. |
| IQ-TMD-02 | Conduct sensitivity reject verification. | Reject sensitivity meets URS Annex11. | Test results and audit trail logs. |
| IQ-TMD-03 | Check audit trail functionality. | Audit trail records all rejects accurately. | Audit trail report. |
Detailed Test Cases
Test Case: IQ-TMD-01
Procedure: Verify that all components of the Inline Tablet Metal Detector are installed as per the manufacturer’s specifications. This includes checking connections, power supply, and alignment.
Acceptance Criteria: All components must be installed correctly, with no missing parts.
Evidence: Completion of the installation checklist and photographs of the installation.
Test Case: IQ-TMD-02
Procedure: Conduct a sensitivity reject verification using standard metal contaminants. Document the results and ensure they meet the specified sensitivity levels.
Acceptance Criteria: The detector must reject all metal contaminants at the sensitivity levels defined in URS Annex11.
Evidence: Test results and signed verification log.
Test Case: IQ-TMD-03
Procedure: Test the audit trail functionality by simulating reject events and verifying that they are logged accurately in the system.
Acceptance Criteria: The audit trail must accurately reflect all reject events with timestamps.
Evidence: Audit trail report showing logged events.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed. A root cause analysis may be required for any critical failures.
Approvals
Prepared By: ______________________ Date: ___________
Approved By: ______________________ Date: ___________