Document Control
Document ID: DQ-HM-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approved By: [Name]
Design Qualification Protocol for Hammer Mill in Solid Dosage Form
Objective: To establish the design qualification for the Hammer Mill used in the production of solid dosage forms, ensuring it meets specified requirements for size reduction.
Scope: This protocol applies to the Hammer Mill utilized in the production area for milling solid dosage forms. It covers the design qualification process, including equipment specifications, critical parameters, and acceptance criteria.
Responsibilities:
- Validation Team: Oversee the execution and documentation of the DQ protocol.
- Production Team: Ensure the Hammer Mill is operated according to the specified parameters.
- Quality Assurance: Review and approve the DQ documentation and results.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) must be completed prior to DQ execution.
Equipment Description: The Hammer Mill is designed for the size reduction of solid dosage forms. It operates by impacting the material with hammers, providing a controlled particle size distribution.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-001 | Verify Speed Settings | Speed within specified range as per URS | Calibration report |
| DQ-002 | Check Screen Output | Output meets particle size distribution as per URS | Particle size analysis report |
| DQ-003 | Monitor Heat Generation | Heat within acceptable limits as per URS | Temperature log |
Detailed Test Cases:
Test Case DQ-001: Verify Speed Settings
Objective: To ensure the Hammer Mill operates at the specified speed.
Procedure: Set the Hammer Mill to the required speed and record the actual speed.
Acceptance Criteria: Speed must be within the range specified in the URS.
Evidence: Provide calibration report documenting speed settings.
Test Case DQ-002: Check Screen Output
Objective: To confirm the particle size distribution of the output meets specifications.
Procedure: Collect samples of the milled product and perform particle size analysis.
Acceptance Criteria: Output must meet the particle size distribution defined in the URS.
Evidence: Include particle size analysis report.
Test Case DQ-003: Monitor Heat Generation
Objective: To ensure that the heat generated during operation is within acceptable limits.
Procedure: Monitor the temperature of the Hammer Mill during operation.
Acceptance Criteria: Temperature must remain within the limits specified in the URS.
Evidence: Provide temperature log documentation.
Deviations:
Any deviations from the acceptance criteria must be documented and approved by Quality Assurance. A root cause analysis should be conducted for any significant deviations.
Approvals:
All sections of this Design Qualification Protocol must be reviewed and approved by the Validation Team and Quality Assurance before implementation.