Installation Qualification Protocol for Manual Inspection Booth in Ophthalmics Production
Document Number: IQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Your Name]
Reviewed by: [Reviewer Name]
Approved by: [Approver Name]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Manual Inspection Booth (Controlled Lux) is installed correctly and operates according to the specified requirements for the production of sterile ophthalmic products.
Scope
This protocol applies to the Manual Inspection Booth used in the production area for the manual inspection of sterile eye drops and eye ointments. It encompasses the installation verification and operational checks necessary to ensure compliance with regulatory standards.
Responsibilities
The following personnel are responsible for executing this protocol:
- Validation Team: Conducts the IQ testing and documentation.
- Quality Assurance: Reviews and approves the protocol.
- Maintenance Team: Provides technical support for equipment setup.
Prerequisites
Before executing this protocol, the following conditions must be met:
- Installation of the Manual Inspection Booth must be completed.
- All relevant personnel must be trained on equipment operation.
- Environmental conditions must be within specified limits.
Equipment Description
The Manual Inspection Booth (Controlled Lux) is designed for the visual inspection of sterile ophthalmic products. It features adjustable lighting to ensure optimal visibility and contrast for inspection purposes.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation location and environmental conditions. | Installation must be in designated area with proper environmental controls. | Installation checklist and environmental monitoring records. |
| IQ-02 | Measure illuminance range. | Illuminance must be within specified range as per URS. | Illuminance measurement records. |
| IQ-03 | Assess background contrast. | Background contrast must meet defined specifications. | Contrast assessment report. |
Detailed Test Cases
Test Case IQ-01: Installation Verification
Objective: Confirm that the Manual Inspection Booth is installed in the correct location.
Procedure: Check the installation site against the approved layout and confirm environmental conditions.
Acceptance Criteria: Installation must be in designated area with proper environmental controls.
Evidence: Document any discrepancies and corrective actions taken.
Test Case IQ-02: Illuminance Measurement
Objective: Verify that the illuminance level is within the required range.
Procedure: Use a calibrated illuminance meter to measure the light levels in the booth.
Acceptance Criteria: Illuminance must be within specified range as per URS.
Evidence: Record measurements and calibration certificates of the meter used.
Test Case IQ-03: Background Contrast Assessment
Objective: Ensure that the background contrast meets specifications for effective inspection.
Procedure: Evaluate the contrast between the inspection surface and the product.
Acceptance Criteria: Background contrast must meet defined specifications.
Evidence: Document the assessment results with visual aids if necessary.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be implemented to address the deviations identified during testing.
Approvals
This protocol must be reviewed and approved by the Quality Assurance Manager and the Validation Lead before execution.