Document Number: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Design Qualification Protocol for Viscometer/Rheometer in NDDS Analytics
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Viscometer/Rheometer is properly designed, installed, and operates according to the specified requirements for NDDS Critical Analytics.
Scope
This protocol applies to the validation of the Viscometer/Rheometer utilized in the Quality Control and Research & Development departments for viscosity/rheology assessments impacting product delivery performance.
Responsibilities
- Validation Team: Execute validation activities and document results.
- Quality Assurance: Review and approve validation documentation.
- Equipment Owner: Ensure equipment availability and maintenance.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation of equipment as per manufacturer’s specifications.
- Training of personnel on equipment operation.
Equipment Description
The Viscometer/Rheometer is an analytical instrument designed to measure the viscosity and rheological properties of materials. It is critical for assessing the delivery performance of NDDS formulations.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify equipment installation and calibration | Installation meets URS Annex11 requirements | Calibration certificate, installation report |
| DQ-001-02 | Conduct accuracy repeatability tests | Repeatability within ±5% of target value | Test results, statistical analysis |
| DQ-001-03 | Audit trail verification | Complete audit trail for all test results | Audit trail logs |
Detailed Test Cases
Test Case 1: Equipment Installation and Calibration
Verify that the Viscometer/Rheometer is installed according to the manufacturer’s specifications and calibrated correctly.
Test Case 2: Accuracy and Repeatability
Perform a series of viscosity measurements to ensure that the instrument provides consistent results within the specified tolerance levels.
Test Case 3: Audit Trail Verification
Review the audit trail generated by the instrument to confirm that all data entries are logged and retrievable for compliance.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan will be required for any major deviations.
Approvals
Prepared by: ____________________ Date: ___________
Reviewed by: ____________________ Date: ___________
Approved by: ____________________ Date: ___________
Data Integrity Checks
- Ensure that data is automatically logged by the instrument.
- Verify that all data entries are time-stamped and user-identified.
- Regularly back up data to prevent loss.