Installation Qualification Protocol for Manual Inspection Booth
Document Number: IQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Manual Inspection Booth is installed and configured according to the specified requirements for the inspection of Nasal and Otic products under controlled lighting conditions.
Scope
This protocol applies to the Manual Inspection Booth located in the Production area and is intended for use in the inspection of both sterile and non-sterile Nasal & Otic products.
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ documentation.
- Maintenance Team: Responsible for ensuring that the equipment is maintained and operational.
Prerequisites
- Installation of the Manual Inspection Booth must be completed.
- All necessary utilities (e.g., power, lighting) must be operational.
- Personnel must be trained on the use of the equipment.
Equipment Description
The Manual Inspection Booth is designed for the manual inspection of Nasal and Otic products. It features adjustable lighting to meet illuminance contrast requirements and is located in a controlled environment to ensure product integrity.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation of the Manual Inspection Booth. | Booth is installed as per specifications. | Installation checklist. |
| IQ-02 | Check illuminance contrast requirements. | Illuminance meets specified criteria. | Illuminance measurement report. |
Detailed Test Cases
Test Case: IQ-01
Objective: Verify the installation of the Manual Inspection Booth.
Procedure: Inspect the booth for compliance with installation specifications.
Acceptance Criteria: The booth must be installed according to the manufacturer’s guidelines.
Evidence: Documented checklist confirming installation.
Test Case: IQ-02
Objective: Validate illuminance contrast requirements.
Procedure: Measure the illuminance at specified points within the booth using a calibrated light meter.
Acceptance Criteria: Illuminance levels must meet the requirements outlined in the URS.
Evidence: Measurement report detailing illuminance levels.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team for further action.
Approvals
Prepared by: ___________________ Date: ___________
Approved by: ___________________ Date: ___________