Installation Qualification Protocol for Automated Visual Inspection Machine
Document Number: IQ-AVIM-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Automated Visual Inspection Machine is installed correctly and operates according to the specified requirements for the inspection of prefilled syringes and cartridges.
Scope
This protocol applies to the installation and qualification of the Automated Visual Inspection Machine in the Production area for the inspection of prefilled syringes and cartridges with a direct product impact.
Responsibilities
- Validation Team: Responsible for the execution of the IQ protocol and documentation.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Engineering: Responsible for the installation and maintenance of the equipment.
Prerequisites
- Completion of equipment installation as per manufacturer’s guidelines.
- Availability of necessary documentation (URS, FAT, etc.).
- Training of personnel on equipment operation and maintenance.
Equipment Description
The Automated Visual Inspection Machine is designed to inspect prefilled syringes and cartridges for defects. It utilizes advanced imaging technology to ensure inspection accuracy and includes reject logic and audit trail logs for compliance and traceability.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify equipment installation according to manufacturer’s specifications. | Installation meets all specified requirements. | Installation checklist and photographic evidence. |
| IQ-02 | Check calibration of inspection parameters. | Calibration within specified limits. | Calibration certificates. |
| IQ-03 | Validate inspection accuracy using known defect samples. | Accuracy ≥ 95% as per URS Annex11. | Test results and reports. |
| IQ-04 | Verify reject logic functionality. | Reject logic functions as intended. | Test results and logs. |
| IQ-05 | Check audit trail logs for integrity. | Audit trail logs are complete and unaltered. | Audit trail log review. |
Detailed Test Cases
Test Case: IQ-01
Procedure: Verify that the Automated Visual Inspection Machine is installed according to the manufacturer’s specifications by reviewing the installation checklist.
Acceptance Criteria: All installation requirements are met.
Evidence: Signed installation checklist and photographs of the installed machine.
Test Case: IQ-02
Procedure: Check the calibration of the inspection parameters using calibrated standards.
Acceptance Criteria: All calibration results must be within specified limits.
Evidence: Calibration certificates and records.
Test Case: IQ-03
Procedure: Validate the inspection accuracy by running known defect samples through the machine.
Acceptance Criteria: The machine must achieve an accuracy of 95% or higher.
Evidence: Test results and accuracy report.
Test Case: IQ-04
Procedure: Test the reject logic by introducing defective samples and observing the machine’s response.
Acceptance Criteria: The machine must reject all defective samples.
Evidence: Test results and rejection logs.
Test Case: IQ-05
Procedure: Review the audit trail logs to ensure they are complete and have not been altered.
Acceptance Criteria: Audit trail logs must show all actions performed on the machine.
Evidence: Audit trail log review documentation.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A deviation report will be generated and reviewed by the Quality Assurance team.
Approvals
Prepared By: [Preparer Name]
Date: [Preparation Date]
Reviewed By: [Reviewer Name]
Date: [Review Date]
Approved By: [Approver Name]
Date: [Approval Date]