Document Control Number: OQ-ZPA-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Approved by: [Approver Name]
Operational Qualification Protocol for Zeta Potential Analyzer
Objective: To validate the operational performance of the Zeta Potential Analyzer for accurate surface charge measurements in compliance with URS Annex11.
Scope: This protocol applies to the Zeta Potential Analyzer utilized in the QC/R&D area for critical NDDS analytics.
Responsibilities:
- Validation Team: Preparation and execution of the protocol.
- Quality Assurance: Review and approval of the protocol.
- Equipment Operator: Conducting tests and documenting results.
Prerequisites:
- Training on Zeta Potential Analyzer operation.
- Completion of Installation Qualification (IQ).
- Availability of calibration standards.
Equipment Description:
The Zeta Potential Analyzer is an instrument used to measure the surface charge of particles in a suspension, providing critical data for NDDS applications. It ensures quality through precise measurements of zeta potential, which is vital for product stability and performance.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify accuracy of zeta potential measurements using standard reference materials. | Measurements must be within ±5% of the known values. | Calibration report and measurement logs. |
| OQ-02 | Assess repeatability by performing multiple measurements on the same sample. | Standard deviation must not exceed 3% of the mean value. | Statistical analysis report. |
| OQ-03 | Review audit trail functionality to ensure data integrity. | All user actions must be logged with timestamps. | Audit trail report. |
Detailed Test Cases:
Test Case OQ-01:
- Use standard reference materials with known zeta potential values.
- Record the measured values and compare with known values.
- Document results in the measurement log.
Test Case OQ-02:
- Prepare the same sample for multiple measurements.
- Perform at least 5 measurements and record results.
- Calculate the mean and standard deviation.
- Document findings in the statistical report.
Test Case OQ-03:
- Access the audit trail feature of the analyzer.
- Review logs for completeness and accuracy.
- Ensure all actions are logged with appropriate timestamps.
- Document findings in the audit trail report.
Deviations: Any deviations from the acceptance criteria must be documented and justified. Investigate root causes and implement corrective actions as necessary.
Approvals:
- Validation Team Lead: ___________________ Date: _____________
- Quality Assurance Manager: ______________ Date: _____________
Data Integrity Checks:
- Ensure all data entries are timestamped and attributed to the respective operator.
- Regularly back up data to prevent loss.
- Review data logs for any anomalies during testing.