Document Control:
Document Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Operational Qualification Protocol for Manual Inspection Booth in Ophthalmics Production
Meta Description: This document outlines the Operational Qualification protocol for the Manual Inspection Booth used in the production of sterile eye drops and eye ointments.
Tags: Equipment Validation, Ophthalmics, Manual Inspection, Sterile Eye Drops, Eye Ointments
Objective
The objective of this protocol is to establish the Operational Qualification (OQ) of the Manual Inspection Booth to ensure it meets the specified requirements for the manual inspection of sterile eye drops and eye ointments.
Scope
This protocol applies to the Manual Inspection Booth utilized in the production area for the manual inspection of ophthalmic products. It covers the critical parameters necessary for ensuring product quality and compliance.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ results.
- Production Personnel: Responsible for operating the equipment during the qualification process.
Prerequisites
- Completion of Installation Qualification (IQ).
- Training of personnel on Manual Inspection Booth operation.
- Availability of necessary tools and materials for testing.
Equipment Description
The Manual Inspection Booth is designed for the manual inspection of sterile eye drops and eye ointments under controlled lighting conditions. It features adjustable illuminance levels to ensure optimal visibility for quality inspection.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Measure illuminance levels at various settings. | Illuminance range must be within specified limits (e.g., 300-1000 lux). | Calibration certificate, measurement logs. |
| OQ-02 | Assess background contrast during inspection. | Contrast ratio must meet defined specifications. | Visual inspection reports, photographic evidence. |
Detailed Test Cases
Test Case OQ-01: Illuminance Measurement
Objective: To verify that the illuminance levels of the Manual Inspection Booth are within the specified range.
Procedure: Use a calibrated light meter to measure the illuminance at multiple settings (low, medium, high). Document the readings.
Acceptance Criteria: All readings must fall within the specified range of 300-1000 lux.
Test Case OQ-02: Background Contrast Assessment
Objective: To ensure the background contrast is suitable for effective inspection.
Procedure: Conduct visual assessments of the background contrast with test samples under controlled lighting. Document observations.
Acceptance Criteria: The background contrast must allow for clear visibility of defects.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed to address the issues identified during testing.
Approvals
Prepared By: [Name] – [Title] – [Date]
Reviewed By: [Name] – [Title] – [Date]
Approved By: [Name] – [Title] – [Date]