Performance Qualification Protocol for the Manual Inspection Booth
Document Number: PQ-MIB-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed by: [Name]
Approval Date: YYYY-MM-DD
Objective
The objective of this Performance Qualification (PQ) protocol is to ensure that the Manual Inspection Booth operates within specified parameters to support the manual inspection of nasal and otic products under controlled lighting conditions.
Scope
This protocol applies to the Manual Inspection Booth utilized in the production area for the inspection of both sterile and non-sterile nasal and otic products.
Responsibilities
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the PQ protocol and results.
- Production Personnel: Operate the Manual Inspection Booth during testing.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the use of the Manual Inspection Booth.
- Availability of necessary equipment and materials for testing.
Equipment Description
The Manual Inspection Booth is designed for visual inspection of products under controlled lighting conditions. It features adjustable lighting to meet illuminance contrast requirements critical for the inspection process.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Measure illuminance levels at various points within the booth. | Illuminance levels must meet specified contrast requirements as per URS. | Calibration certificate and measurement logs. |
Detailed Test Cases
Test Case 1: Illuminance Measurement
Objective: To verify that the illuminance levels within the booth meet the required specifications.
Procedure: Use a calibrated light meter to measure the illuminance at designated points within the booth. Record the readings.
Acceptance Criteria: Illuminance must be within the range specified in the URS.
Evidence: Documented measurement logs and calibration certificates.
Deviations
Any deviations from the planned protocol must be documented and assessed for impact on the qualification results. A deviation report should be generated for any significant findings.
Approvals
By signing below, the following individuals confirm their approval of this Performance Qualification Protocol.
Validation Team Lead: ______________________ Date: __________
Quality Assurance Manager: ______________________ Date: __________