Standard Operating Procedure for the Validation of Nano Tracking Analysis (NTA) System
Purpose: This SOP outlines the validation process for the Nano Tracking Analysis (NTA) System, ensuring compliance with regulatory requirements and maintaining product quality.
Scope: This procedure applies to the validation of the NTA System utilized in Quality Control (QC) and Research & Development (R&D) for particle concentration and size analysis.
Definitions:
- NTA: Nano Tracking Analysis, a technique for measuring particle size and concentration.
- CQA: Critical Quality Attributes.
- CPP: Critical Process Parameters.
- DQ/IQ/OQ/PQ: Design Qualification/Installation Qualification/Operational Qualification/Performance Qualification.
Roles:
- Validation Team: Responsible for planning and executing the validation activities.
- Quality Assurance: Ensures compliance with regulatory standards and oversees validation documentation.
- Operators: Perform routine operations and maintenance of the NTA System.
Lifecycle Procedure:
- Design Qualification (DQ): Verify that the NTA System meets user requirements and specifications.
- Installation Qualification (IQ): Confirm that the system is installed according to manufacturer specifications.
- Operational Qualification (OQ): Validate that the system operates within defined parameters.
- Performance Qualification (PQ): Ensure the system performs effectively in real-world conditions.
Good Documentation Practices (GDP) Controls: All validation activities and results must be documented accurately, maintaining traceability and compliance with regulatory standards.
Acceptance Criteria Governance: Acceptance criteria must align with User Requirements Specification (URS) and Annex 11 guidelines. All critical attributes must be met for validation success.
Calibration and Preventive Maintenance (PM) Governance: The NTA System must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal policies.
Change Control Triggers: Any changes to the NTA System, including software updates or hardware modifications, must initiate a change control process.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or when significant changes occur. Periodic reviews should assess system performance and compliance.
Records and Attachments List:
- Validation Plan
- Validation Protocols (DQ, IQ, OQ, PQ)
- Calibration Records
- Preventive Maintenance Logs
- Change Control Documentation
- Periodic Review Reports