Document Control:
Document Number: PQ-DLS-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Dynamic Light Scattering Analyzer
Objective
The objective of this protocol is to validate the Dynamic Light Scattering (DLS) Analyzer for particle size and PDI measurement, ensuring it meets the specified acceptance criteria and regulatory requirements.
Scope
This protocol applies to the DLS Analyzer used in the QC/R&D area for critical NDDS analytics. It covers the performance qualification activities related to the equipment’s operational capabilities.
Responsibilities
The following personnel are responsible for the execution and approval of this protocol:
- Validation Lead: [Name]
- Quality Assurance: [Name]
- Laboratory Personnel: [Name]
Prerequisites
- Completion of Installation Qualification (IQ)
- Completion of Operational Qualification (OQ)
- Training of personnel on DLS Analyzer operation
Equipment Description
The Dynamic Light Scattering (DLS) Analyzer is an instrument used for measuring particle size and polydispersity index (PDI) in suspension and emulsion formulations. It provides critical data for formulation development and quality control.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-DLS-01 | Verify size accuracy using standard reference materials. | Size measurements within ±5% of the reference value. | Calibration report, measurement logs. |
| PQ-DLS-02 | Assess PDI repeatability over 10 consecutive measurements. | PDI values must be within ±0.05 of the mean. | Measurement logs, statistical analysis report. |
| PQ-DLS-03 | Audit trail review for data integrity. | Complete and accurate audit trail maintained. | Audit trail report, system logs. |
Detailed Test Cases
Test Case 1: Size Accuracy
Procedure: Measure the size of standard reference materials. Compare results with accepted values.
Acceptance Criteria: Size measurements must be within ±5% of the reference value.
Expected Results: Documented results showing compliance.
Test Case 2: PDI Repeatability
Procedure: Perform 10 consecutive measurements of the same sample and calculate the mean and standard deviation.
Acceptance Criteria: PDI values must be within ±0.05 of the mean.
Expected Results: Documented results showing compliance.
Test Case 3: Data Integrity Audit Trail
Procedure: Review the audit trail for completeness and accuracy.
Acceptance Criteria: Audit trail must show all user interactions, data entries, and modifications.
Expected Results: Documented results of the audit trail review.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A deviation report must be generated and approved by the Validation Lead and Quality Assurance.
Approvals
This protocol requires the following approvals:
- Validation Lead: ___________________ Date: ____________
- Quality Assurance: ___________________ Date: ____________
- Laboratory Manager: ___________________ Date: ____________
Data Integrity Checks
- Ensure all measurement data is automatically logged by the DLS Analyzer.
- Verify that user access controls are in place to prevent unauthorized data manipulation.
- Conduct periodic reviews of data integrity logs to ensure compliance with regulatory standards.