Document ID: OQ-AVI-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Automated Visual Inspection Machine
Objective: To validate the performance of the Automated Visual Inspection (AVI) Machine for the inspection of particulates and cosmetics in sterile eye drops and eye ointments.
Scope: This protocol applies to the operational qualification of the AVI Machine used in the production area for ophthalmic products, ensuring compliance with regulatory standards and internal quality requirements.
Responsibilities:
- Validation Team: Execute and document the qualification activities.
- Quality Assurance: Review and approve the protocol and reports.
- Production Team: Provide necessary support and access to equipment.
Prerequisites:
- Installation Qualification (IQ) completed.
- Operator training completed.
- Availability of necessary materials and resources.
Equipment Description:
The Automated Visual Inspection Machine is designed to inspect sterile eye drops and eye ointments for particulates and cosmetic defects. It utilizes advanced imaging technology and algorithms to ensure high detection sensitivity and maintain an audit trail for reject logic.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-AVI-01 | Verify detection sensitivity with standard particulates. | Detect 100% of specified particulates. | Test results report. |
| OQ-AVI-02 | Audit trail verification for reject logic. | Audit trail must be complete and accurate. | Audit trail log. |
| OQ-AVI-03 | Review system alarm and alert functionalities. | All alarms must trigger appropriately. | Alarm log report. |
Detailed Test Cases:
- OQ-AVI-01: Conduct tests with known particulate sizes and types. Document detection rates and compare against acceptance criteria.
- OQ-AVI-02: Simulate product rejection scenarios and validate that the audit trail logs all necessary details accurately.
- OQ-AVI-03: Test the system’s response to various alarms. Ensure that all alarms are logged and can be retrieved for review.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team for further action.
Approvals:
- Validated By: [Insert Name]
- Date: [Insert Date]
- Approved By: [Insert Name]
- Date: [Insert Date]
CSV Requirements: Data integrity checks will include:
- Regular system backups to prevent data loss.
- Access controls to ensure only authorized personnel can modify settings or data.
- Audit trail reviews to confirm all changes are logged and traceable.