Document Number: DQ-OSD-001
Version: 1.0
Date: 2023-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Design Qualification Protocol for Jet Mill / Micronizer in Solid Dosage Form Production
Objective: To ensure that the Jet Mill / Micronizer is qualified for use in the production of solid dosage forms, meeting all specified requirements and operational parameters.
Scope: This protocol covers the qualification of the Jet Mill / Micronizer utilized in the milling area for the micronization of solid dosage forms, impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Team: Responsible for operating the equipment as per validated procedures.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) must be completed prior to DQ.
- Training of personnel on the operation of the Jet Mill / Micronizer.
Equipment Description: The Jet Mill / Micronizer is designed for the micronization of solid dosage forms through high-velocity air streams, ensuring precise particle size distribution.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify air pressure settings at operational levels. | Air pressure must be within specified range as per URS. | Calibration certificate and log. |
| DQ-02 | Measure feed rate during operation. | Feed rate must meet URS specifications. | Operational log and data sheet. |
| DQ-03 | Assess output particle size distribution (PSD). | PSD must align with URS acceptance criteria. | Particle size analysis report. |
Detailed Test Cases:
- Test Case DQ-01: Measure air pressure using calibrated gauge. Record readings at startup and during operation. Compare against URS.
- Test Case DQ-02: Monitor feed rate using flow meter. Ensure consistency and record fluctuations. Compare against URS specifications.
- Test Case DQ-03: Collect samples for PSD analysis post-micronization. Use laser diffraction method and compare results with URS.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be implemented to address any issues identified during the qualification process.
Approvals:
- Prepared By: ______________________ Date: ___________
- Reviewed By: ______________________ Date: ___________
- Approved By: ______________________ Date: ___________