Document Control:
Document Number: DQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Multi Mill in Solid Dosage Form Production
Objective: To establish a Design Qualification (DQ) protocol for the Multi Mill utilized in the milling and sizing of powders and granules in solid dosage form production.
Scope: This protocol applies to the Multi Mill located in the Production/Milling area, addressing its use in direct impact on product quality.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Review and approve the DQ protocol and results.
- Production Team: Ensure equipment is operated per the protocol requirements.
Prerequisites:
- Completed User Requirement Specification (URS).
- Installation Qualification (IQ) completed.
- Training records for personnel operating the Multi Mill.
Equipment Description: The Multi Mill is designed for milling and sizing of powders and granules, featuring adjustable rotor speed and screen integrity to achieve desired particle size distribution (PSD).
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify rotor speed settings. | Rotor speed must be within specified range as per URS. | Calibration records. |
| DQ-02 | Check screen integrity. | No visible damage; screen must meet URS specifications. | Inspection report. |
| DQ-03 | Assess output particle size distribution (PSD). | PSD must conform to specifications outlined in URS. | PSD analysis report. |
Detailed Test Cases:
- Test Case DQ-01: Measure rotor speed using calibrated tachometer. Document readings and compare against URS.
- Test Case DQ-02: Conduct visual inspection of screen for wear and tear. Document findings in inspection report.
- Test Case DQ-03: Perform PSD analysis using appropriate sieving method. Document results and compare to URS specifications.
Deviations: Any deviations from the acceptance criteria must be documented, investigated, and resolved prior to final approval of the DQ protocol.
Approvals:
- Prepared By: [Insert Name]
- Reviewed By: [Insert Name]
- Approved By: [Insert Name]