Document Number: DQ-OSD-WB-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Design Qualification Protocol for Weighing Balance in Solid Dosage Form
Objective: To establish a Design Qualification (DQ) protocol for the Weighing Balance (Platform/Floor) used in the production and dispensing of solid dosage forms, ensuring it meets all specified requirements and acceptance criteria.
Scope: This protocol covers the qualification of the Weighing Balance in the Production/Dispensing area, focusing on its use for weighing raw materials (RM) and intermediate bulk containers (IBCs) with a direct impact on product quality.
Responsibilities:
- Validation Team: Overall execution and documentation of the DQ protocol.
- Quality Assurance: Review and approval of the DQ protocol and results.
- Operations: Provide access to the equipment and assist in testing.
Prerequisites:
- Completion of User Requirement Specifications (URS).
- Availability of the Weighing Balance and necessary accessories.
- Trained personnel for conducting the qualification tests.
Equipment Description: The Weighing Balance (Platform/Floor) is an instrument designed for precise measurement of raw materials and IBCs in the production area. It features a digital display, tare function, and calibration capabilities.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Perform accuracy linearity corner test. | Accuracy within ±0.1g at all points. | Calibration report. |
Detailed Test Cases:
- Accuracy Linearity Corner Test:
- Weigh standard weights at low, mid, and high ranges.
- Document the weight displayed versus actual weight.
- Calculate the percentage deviation from the actual weight.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. Appropriate corrective actions should be initiated to address any discrepancies.
Approvals:
- Prepared By: ______________________ Date: ___________
- Reviewed By: ______________________ Date: ___________
- Approved By: ______________________ Date: ___________