Document Number: DQ-ZPA-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Design Qualification Protocol for Zeta Potential Analyzer
Meta Description: This document outlines the Design Qualification (DQ) protocol for the Zeta Potential Analyzer, focusing on critical analytics in NDDS for QC/R&D applications.
Tags: Equipment Validation, DQ Protocol, Zeta Potential Analyzer, NDDS, QC, R&D
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Zeta Potential Analyzer meets the required specifications and is suitable for its intended use in measuring surface charge in NDDS applications.
Scope
This DQ protocol applies to the Zeta Potential Analyzer utilized in the Quality Control (QC) and Research & Development (R&D) areas for critical NDDS analytics.
Responsibilities
- Validation Team: Responsible for the execution and documentation of the DQ protocol.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol.
- Equipment Owner: Responsible for ensuring that the equipment is maintained and calibrated.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) must be completed prior to DQ.
- Operator training on the Zeta Potential Analyzer.
Equipment Description
The Zeta Potential Analyzer is an instrument designed to measure the surface charge of particles in suspension, providing critical data for the formulation and stability of NDDS products.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001 | Verify accuracy of measurements using known standards. | Accuracy within ±5% of the known value. | Calibration report. |
| DQ-002 | Assess repeatability by conducting multiple measurements. | Standard deviation of measurements < 2%. | Measurement log. |
| DQ-003 | Audit trail verification for data integrity. | Complete and accurate audit trail maintained. | Audit trail report. |
Detailed Test Cases
Test Case DQ-001: Accuracy Verification
Procedure: Utilize a certified standard solution to measure zeta potential and compare results.
Acceptance Criteria: Results must be within ±5% of the certified value.
Evidence: Calibration report must be documented.
Test Case DQ-002: Repeatability Assessment
Procedure: Conduct five consecutive measurements of the same sample.
Acceptance Criteria: The standard deviation of the measurements must be < 2%.
Evidence: Measurement log must be maintained.
Test Case DQ-003: Audit Trail Verification
Procedure: Review the audit trail generated by the Zeta Potential Analyzer.
Acceptance Criteria: Ensure all actions are recorded and retrievable.
Evidence: Audit trail report must be generated and reviewed.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the validation team and Quality Assurance for potential impact assessment.
Approvals
Approved by: [Approver Name]
Date of Approval: [Approval Date]