Design Qualification Protocol for Rotary Sifter
Document Number: DQ-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Objective
The objective of this Design Qualification (DQ) protocol is to verify that the Rotary Sifter used for sifting powders in the production area meets the specified requirements and is suitable for its intended use.
Scope
This protocol applies to the Design Qualification of the Rotary Sifter used in the production of solid dosage forms (OSD) within the manufacturing facility.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for providing technical support and ensuring equipment compliance.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) completed and approved.
- Access to relevant standard operating procedures (SOPs).
Equipment Description
The Rotary Sifter is designed for sifting powders to ensure uniform particle size distribution. Key features include adjustable speed settings and a robust screen to maintain screen integrity during operation.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T01 | Verify speed settings during operation. | Speed must be within specified range as per URS. | Calibration records, speed test results. |
| T02 | Check screen integrity before and after operation. | No visible damage or wear on the screen. | Photographic evidence, inspection report. |
Detailed Test Cases
Test Case T01: Speed Verification
Procedure: Measure the speed of the Rotary Sifter using a calibrated tachometer during operation.
Expected Result: Speed readings should match the specified range defined in the URS document.
Test Case T02: Screen Integrity Inspection
Procedure: Conduct a visual inspection of the sifter screen before and after use. Document any findings.
Expected Result: The screen should show no signs of damage or degradation.
Deviations
Any deviations from the acceptance criteria must be documented in the deviation log and reviewed by the Quality Assurance team for further action.
Approvals
Prepared by: ______________________ Date: ___________
Approved by: ______________________ Date: ___________