Document Number: DQ-OSD-VB-001
Version: 1.0
Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for V Blender in Solid Dosage Form
Objective: To establish a Design Qualification (DQ) protocol for the V Blender used in the blending of powders and granules, ensuring compliance with regulatory standards and operational requirements.
Scope: This protocol applies to the V Blender utilized in the Production/Blending area for solid dosage forms. It covers the assessment of equipment design, functionality, and suitability for intended use.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol.
- Engineering: Responsible for providing technical support and documentation related to the V Blender.
Prerequisites:
- Completion of User Requirements Specification (URS) for the V Blender.
- Installation Qualification (IQ) protocol completed and approved.
Equipment Description:
The V Blender is a cylindrical blending machine designed for the uniform mixing of powders and granules. It operates at variable RPM settings and is equipped with a fill level indicator to ensure proper loading of materials.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-VB-01 | Verify RPM settings during operation. | RPM within ±10% of specified range. | Calibration certificate, operational log. |
| DQ-VB-02 | Check fill level indicator functionality. | Indicator accurately reflects fill level. | Operational log, visual inspection report. |
| DQ-VB-03 | Measure blending time for specified batch size. | Blending time within defined limits. | Blending time log, batch records. |
Detailed Test Cases:
Test Case DQ-VB-01: RPM Verification
Procedure: Set the V Blender to the specified RPM and monitor using a calibrated tachometer.
Expected Result: RPM should remain within ±10% of the specified range.
Test Case DQ-VB-02: Fill Level Indicator Check
Procedure: Load the blender to the specified fill level and verify the indicator’s accuracy.
Expected Result: Fill level indicator should accurately reflect the actual fill level.
Test Case DQ-VB-03: Blending Time Measurement
Procedure: Start blending operation and time the process for the specified batch size.
Expected Result: Blending should be completed within defined time limits as per URS.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team.
Approvals:
Prepared By: ____________________ Date: ____________
Approved By: ____________________ Date: ____________