Document Control:
Document Number: PQ-NTA-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: 2023-10-01
Performance Qualification Protocol for Nano Tracking Analysis System
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Nano Tracking Analysis (NTA) System operates according to its intended use for particle concentration and size analysis, ensuring compliance with regulatory requirements and internal standards.
Scope
This protocol applies to the Nano Tracking Analysis (NTA) System used in the Quality Control (QC) and Research & Development (R&D) areas for critical NDDS analytics.
Responsibilities
The following personnel are responsible for the execution and approval of this PQ protocol:
- Validation Lead: [Name]
- Quality Assurance: [Name]
- Laboratory Personnel: [Name]
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the use of the NTA System.
- Availability of all required materials and standards for testing.
Equipment Description
The Nano Tracking Analysis (NTA) System is an advanced instrument used for measuring the size and concentration of nanoparticles in a liquid suspension. It employs a unique imaging technique to provide accurate and reproducible data relevant to critical quality attributes (CQA) and critical process parameters (CPP).
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-NTA-001 | Perform accuracy checks using certified reference materials. | Results must fall within ±5% of the certified values. | Test report with results and calibration data. |
| PQ-NTA-002 | Conduct data integrity audit trail review. | All data entries must be traceable and logged. | Audit trail report. |
Detailed Test Cases
Test Case 1: Accuracy Verification
Purpose: To ensure the NTA System provides accurate measurements.
Procedure: Use certified reference materials to perform multiple measurements. Record the results and compare them with the certified values.
Expected Outcome: All results should be within ±5% of the certified values.
Test Case 2: Data Integrity Audit Trail
Purpose: To verify that all data generated by the NTA System is properly logged and traceable.
Procedure: Review the audit trail for data entries, modifications, and deletions. Ensure all actions are documented with timestamps and user identification.
Expected Outcome: All data entries must be traceable and logged appropriately.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions should be taken as necessary.
Approvals
The following signatures are required to approve this Performance Qualification Protocol:
_____________________
Validation Lead
_____________________
Quality Assurance
_____________________
Laboratory Personnel