Document ID: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Design Qualification Protocol for Dynamic Light Scattering (DLS) Analyzer
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Dynamic Light Scattering (DLS) Analyzer is properly designed and meets the specified requirements for particle size and PDI measurement.
Scope
This protocol applies to the installation and qualification of the DLS Analyzer used in the QC/R&D area for the measurement of critical quality attributes (CQA) and critical process parameters (CPP).
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol.
- Equipment Owner: Responsible for ensuring the DLS Analyzer is available and maintained.
Prerequisites
- Availability of the DLS Analyzer.
- Completion of User Requirement Specification (URS) as per Annex 11.
- Training of personnel on DLS Analyzer operation.
Equipment Description
The Dynamic Light Scattering (DLS) Analyzer is an instrument designed for measuring particle size and polydispersity index (PDI) of samples in a liquid medium. It utilizes laser light scattering techniques to provide accurate size measurements.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify size accuracy | Size measurements within ±5% of expected values | Calibration report |
| DQ-02 | Assess PDI repeatability | PDI values within ±0.1 for repeat measurements | Test run data |
| DQ-03 | Check audit trail functionality | Complete audit trail for all measurements | System log review |
Detailed Test Cases
Test Case DQ-01: Size Accuracy
Procedure: Measure size of standard particles and compare to expected sizes.
Acceptance Criteria: Size measurements must be within ±5% of expected values.
Evidence: Calibration report demonstrating compliance.
Test Case DQ-02: PDI Repeatability
Procedure: Conduct multiple measurements of a standard sample and calculate the PDI.
Acceptance Criteria: PDI values must be within ±0.1 for all measurements.
Evidence: Test run data with statistical analysis.
Test Case DQ-03: Audit Trail
Procedure: Review system logs to ensure all measurements are recorded.
Acceptance Criteria: Complete and accessible audit trail for all operations.
Evidence: System log review documentation.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A corrective action plan should be developed for any critical failures observed during testing.
Approvals
Approved By: [Name, Title]
Date of Approval: [Date]