Performance Qualification Protocol for Manual Inspection Booth in Ophthalmics
Document Control:
- Document Number: PQ-001
- Version: 1.0
- Effective Date: [Insert Date]
- Review Date: [Insert Date]
- Prepared By: [Insert Name]
- Approved By: [Insert Name]
Objective:
The objective of this Performance Qualification (PQ) protocol is to verify that the Manual Inspection Booth operates within the specified parameters to ensure the quality 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.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Team: Responsible for ensuring the equipment is maintained and calibrated.
Prerequisites:
- Calibration of the Manual Inspection Booth must be completed prior to PQ execution.
- All personnel must be trained on the use of the Manual Inspection Booth.
Equipment Description:
The Manual Inspection Booth is designed to provide a controlled environment for the visual inspection of sterile ophthalmic products. Key features include controlled illuminance and background contrast settings to facilitate accurate inspections.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Measure illuminance levels at specified locations in the booth. | Illuminance range must be within specified limits as per URS. | Calibration records and measurement logs. |
| PQ-02 | Evaluate background contrast during inspection. | Background contrast must meet the requirements outlined in the URS. | Visual inspection report and photographic evidence. |
Detailed Test Cases:
- Test Case PQ-01: Verify illuminance levels. Use a calibrated lux meter to measure illuminance at each designated point within the booth. Document all readings and compare to acceptance criteria.
- Test Case PQ-02: Assess background contrast. Conduct a visual inspection under controlled conditions, ensuring that the background contrast is adequate for product evaluation. Document findings and any discrepancies.
Deviations:
Any deviations from the acceptance criteria must be documented in the deviation log, including potential impact on product quality and proposed corrective actions.
Approvals:
- Prepared By: ____________________ Date: __________
- Reviewed By: ____________________ Date: __________
- Approved By: ____________________ Date: __________