Design Qualification Protocol for Manual Inspection Booth Used in Ophthalmics
Document Control:
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Manual Inspection Booth (Controlled Lux) is suitable for its intended use in the production of sterile ophthalmic products, specifically eye drops and eye ointments.
Scope
This protocol applies to the Manual Inspection Booth utilized in the production area for the manual inspection of sterile ophthalmic products. It encompasses the verification of critical parameters that affect product quality.
Responsibilities
The following personnel are responsible for the execution and approval of this DQ protocol:
- Validation Manager: Overall oversight and approval.
- Quality Assurance: Review and ensure compliance with acceptance criteria.
- Production Staff: Execute the test plan and document findings.
Prerequisites
Prior to executing this DQ protocol, the following prerequisites must be met:
- Installation of the Manual Inspection Booth in the designated production area.
- Completion of installation qualification (IQ) for the equipment.
- Availability of the User Requirement Specification (URS) document.
Equipment Description
The Manual Inspection Booth (Controlled Lux) is designed to provide a controlled environment for the manual inspection of sterile ophthalmic products. Key features include adjustable lighting and ergonomic design to facilitate thorough inspection while minimizing contamination risk.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-01 | Measure illuminance levels in the booth. | Illuminance range must be within [insert range] lux. | Calibration certificates and measurement logs. |
| DQ-02 | Assess background contrast during inspection. | Contrast ratio must meet specifications outlined in URS. | Visual assessment reports and photographic evidence. |
Detailed Test Cases
Test Case 1: Illuminance Measurement
Procedure: Utilize a calibrated lux meter to measure the illuminance within the booth at various settings. Record the values.
Acceptance Criteria: The illuminance must fall within the specified range as per the URS.
Evidence: Document the readings and attach calibration certificates of the lux meter.
Test Case 2: Background Contrast Assessment
Procedure: Conduct a visual inspection using a standard sample to evaluate background contrast under different lighting conditions.
Acceptance Criteria: The contrast ratio must meet the requirements outlined in the URS.
Evidence: Provide visual inspection reports and photographs showing the contrast evaluation.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed. A root cause analysis should be conducted, and corrective actions must be implemented prior to approval of the DQ protocol.
Approvals
By signing below, the responsible parties acknowledge that the DQ protocol has been reviewed and approved:
_________________________ Validation Manager
_________________________ Quality Assurance
_________________________ Production Staff