Document ID: DQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for De-lumper / Lump Breaker in Solid Dosage Form Validation
Objective: To establish the design qualification for the De-lumper / Lump Breaker used in the production of solid dosage forms, ensuring it meets the required specifications and operational standards.
Scope: This protocol applies to the validation of the De-lumper / Lump Breaker equipment in the production area, specifically for breaking lumps in powder and granules.
Responsibilities:
- Validation Team: Prepare and execute the DQ protocol.
- Quality Assurance: Review and approve the DQ documentation.
- Production Team: Provide insights on operational requirements.
Prerequisites:
- Completion of User Requirements Specification (URS).
- Availability of equipment and operational manuals.
- Training of personnel on equipment operation.
Equipment Description: The De-lumper / Lump Breaker is designed to break down large lumps in powder and granules, ensuring a uniform particle size for optimal processing in solid dosage form production. The critical parameters for operation include blade speed and torque.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001 | Verify blade speed at operational settings. | Blade speed within specified range as per URS. | Calibration report. |
| DQ-002 | Measure torque during operation. | Torque levels must meet URS specifications. | Torque measurement logs. |
Detailed Test Cases:
- Test Case 1: Check blade speed.
- Procedure: Run the equipment at specified speeds and document readings.
- Acceptance Criteria: Speeds must be within the range specified in the URS.
- Evidence: Speed log sheets and equipment settings.
- Test Case 2: Verify torque measurement.
- Procedure: Operate the equipment and measure torque using a calibrated torque meter.
- Acceptance Criteria: Torque must be within URS-defined limits.
- Evidence: Torque measurement logs and calibration certificates.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A formal deviation report should be generated for each incident.
Approvals:
- Prepared By: [Insert Name]
- Reviewed By: [Insert Name]
- Approved By: [Insert Name]