Document ID: DQ-OSD-001
Version: 1.0
Date: [Insert Date]
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Design Qualification Protocol for Co-Mill / Conical Mill in Solid Dosage Form Production
Objective: To establish the design qualification for the Co-Mill / Conical Mill used in the production of solid dosage forms, ensuring it meets the specified requirements for de-agglomeration and sizing.
Scope: This protocol applies to the validation of the Co-Mill / Conical Mill within the Production/Milling area, affecting the direct product impact with major criticality.
Responsibilities:
- Validation Team: Prepare and execute the DQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Operate the equipment during validation testing.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) must be completed.
- Personnel training on equipment operation.
Equipment Description: The Co-Mill / Conical Mill is designed for de-agglomeration and sizing of solid dosage forms. It utilizes an impeller mechanism to achieve desired particle size distribution (PSD).
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify impeller speed settings. | Within specified range as per URS. | Calibration report. |
| DQ-02 | Assess screen size compatibility. | Screen size matches URS requirements. | Screen size verification report. |
| DQ-03 | Evaluate output PSD. | Output PSD meets specifications in URS. | PSD analysis report. |
Detailed Test Cases:
- Test Case DQ-01: Set the impeller speed to the specified settings as per URS. Measure and document the actual speed using a calibrated RPM meter.
- Test Case DQ-02: Install the specified screen size and verify it against the URS requirements. Document the screen size and any discrepancies.
- Test Case DQ-03: Conduct a particle size analysis of the output material to ensure it meets the specifications outlined in the URS.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions should be implemented as necessary.
Approvals:
- Prepared by: ________________________ Date: __________
- Reviewed by: ________________________ Date: __________
- Approved by: ________________________ Date: __________