Document ID: OQ-DLS-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approval Date: YYYY-MM-DD
Operational Qualification Protocol for Dynamic Light Scattering (DLS) Analyzer
Objective: To establish the operational qualification of the Dynamic Light Scattering (DLS) Analyzer for particle size and PDI measurement, ensuring compliance with the defined acceptance criteria.
Scope: This protocol applies to the Dynamic Light Scattering (DLS) Analyzer used in the Quality Control and Research & Development departments for critical NDDS analytics.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Equipment Owner: Ensure the DLS Analyzer is maintained and calibrated prior to OQ execution.
Prerequisites:
- Equipment must be installed and calibrated according to manufacturer’s specifications.
- All personnel involved must be trained in the operation of the DLS Analyzer.
- Relevant SOPs must be reviewed and understood.
Equipment Description:
The Dynamic Light Scattering (DLS) Analyzer is an instrument used for measuring particle size and polydispersity index (PDI) in various samples. It operates on the principle of analyzing the scattering of laser light by particles in suspension.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify size accuracy by measuring standard size particles. | Size measurements within ±5% of known values. | Measurement report and calibration certificate. |
| OQ-02 | Assess PDI repeatability by conducting multiple measurements. | PDI values must have a standard deviation < 0.05. | Statistical analysis report. |
| OQ-03 | Check audit trail functionality by reviewing data logs. | All data entries must be timestamped and attributed to user IDs. | Audit log report. |
Detailed Test Cases:
- Test Case OQ-01: Measure known standard size particles (e.g., 100 nm, 200 nm) and record the results. Compare against expected values to ensure accuracy.
- Test Case OQ-02: Measure PDI for a homogenous sample five times, calculating the standard deviation of the results.
- Test Case OQ-03: Access the DLS Analyzer’s audit trail and verify that all measurements are logged with appropriate timestamps and user IDs.
Data Integrity Checks:
- Ensure that all data generated during the qualification is backed up to a secure location.
- Verify that user access controls are in place to prevent unauthorized data manipulation.
- Conduct periodic reviews of the audit trail to ensure compliance with data integrity standards.
Deviations: Any deviations from the acceptance criteria must be documented, investigated, and resolved prior to final approval of the OQ protocol.
Approvals:
- Validation Team Lead: ______________________ Date: __________
- Quality Assurance: ______________________ Date: __________
- Equipment Owner: ______________________ Date: __________