Document Number: PQ-LD-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Performance Qualification Protocol for Laser Diffraction Particle Size Analyzer
Objective: To establish a comprehensive Performance Qualification (PQ) protocol for the Laser Diffraction Particle Size Analyzer, ensuring that it meets the required specifications for particle size distribution analysis.
Scope: This protocol applies to the Laser Diffraction Particle Size Analyzer used in the QC/R&D departments for critical NDDS analytics, focusing on the accuracy, repeatability, and audit trail of the instrument.
Responsibilities:
- Validation Team: Prepare and execute the PQ protocol.
- Quality Assurance: Review and approve the PQ documentation.
- Laboratory Personnel: Conduct tests as per the protocol.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the operation of the Laser Diffraction Particle Size Analyzer.
- Availability of all necessary materials and standards for testing.
Equipment Description: The Laser Diffraction Particle Size Analyzer is an advanced instrument designed to measure particle size distribution using laser diffraction technology. It is critical for ensuring product quality in NDDS formulations.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify accuracy using standard particle size reference materials. | Accuracy within ±5% of known values. | Calibration report and test results. |
| PQ-02 | Assess repeatability through multiple measurements of the same sample. | Standard deviation < 2% across measurements. | Statistical analysis report. |
| PQ-03 | Audit trail verification through software logs. | Complete and unaltered audit trail available for all tests. | Audit trail logs. |
Detailed Test Cases:
- Test Case for PQ-01: Conduct three measurements of standard reference material. Record values and calculate accuracy.
- Test Case for PQ-02: Measure the same sample five times. Calculate the mean and standard deviation of the measurements.
- Test Case for PQ-03: Review software logs for any discrepancies or alterations. Ensure logs are complete and accessible.
Deviations: Any deviations from the acceptance criteria must be documented and justified. A deviation report should be submitted for review.
Approvals:
- Prepared By: [Name]
- Reviewed By: [Name]
- Approved By: [Name]
Data Integrity Checks:
- Ensure all data entries are timestamped and user-identified in the system.
- Implement regular backups of all data and logs.
- Conduct periodic audits of data integrity and access controls.