Document Number: PQ-AVI-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Performance Qualification Protocol for Automated Visual Inspection Machine in Ophthalmics
Meta Description: This document outlines the Performance Qualification protocol for the Automated Visual Inspection Machine used in the production of sterile eye drops and ointments.
Tags: Equipment Validation, Performance Qualification, Ophthalmics, Automated Visual Inspection
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Automated Visual Inspection (AVI) Machine operates according to the specified requirements and consistently meets acceptance criteria for inspecting particulates and cosmetics in sterile eye drops and ointments.
Scope
This protocol applies to the Automated Visual Inspection Machine used in the production area for the inspection of sterile ophthalmic products. It encompasses the validation of critical parameters, including detection sensitivity, reject logic, and audit trail functionality.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for operating the AVI Machine during the qualification process.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ) for the AVI Machine.
- Training of personnel on the operation of the AVI Machine.
- Availability of necessary materials and equipment for testing.
Equipment Description
The Automated Visual Inspection (AVI) Machine is designed to inspect sterile ophthalmic products for particulates and cosmetic defects. The equipment features advanced detection sensitivity, reject logic, and maintains an audit trail for compliance and traceability.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Verify detection sensitivity with known standards. | Detection sensitivity meets or exceeds specifications. | Test report and raw data. |
| TP-002 | Assess reject logic functionality. | All defective units are rejected as per criteria. | Log of rejected units. |
| TP-003 | Verify audit trail functionality. | Audit trail is complete and accessible. | Audit trail report. |
Detailed Test Cases
Test Case 1: Detection Sensitivity
Objective: To ensure the AVI Machine can detect specified particulates.
Procedure: Run a series of tests using known particulate standards at varying sizes and concentrations.
Acceptance Criteria: The machine must detect particulates at the defined sensitivity threshold.
Expected Outcome: All particulates above threshold are detected; results logged accurately.
Test Case 2: Reject Logic
Objective: To verify that defective units are correctly rejected by the AVI Machine.
Procedure: Introduce known defective units into the inspection process and observe the machine’s response.
Acceptance Criteria: All defective units must be rejected, and the reasons logged.
Expected Outcome: Defective units are identified and rejected as per the logic defined.
Test Case 3: Audit Trail
Objective: To confirm that the audit trail captures all relevant data.
Procedure: Review the audit trail after conducting tests to ensure all actions are recorded.
Acceptance Criteria: Audit trail must be complete, showing timestamps and user actions.
Expected Outcome: Audit trail is accessible and complete for review.
Deviations
Any deviations from the protocol must be documented and assessed for impact on validation results. A formal deviation report must be generated for approval.
Approvals
This Performance Qualification protocol requires approval from the Validation Manager and Quality Assurance prior to execution. Signatures below indicate approval.
_________________________ Validation Manager
_________________________ Quality Assurance