Design Qualification Protocol for Fitz Mill / Comminuting Mill in Solid Dosage Form
Document Number: DQ-FM-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Fitz Mill / Comminuting Mill is designed and installed in accordance with user requirements and applicable regulations, ensuring it meets the necessary specifications for size reduction in solid dosage form production.
Scope
This protocol applies to the Fitz Mill / Comminuting Mill used in the Production/Milling area for size reduction of solid dosage forms. It encompasses all aspects of the equipment’s design, installation, and operational qualification.
Responsibilities
- Validation Team: Responsible for the development, execution, and documentation of the DQ protocol.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and associated documents.
- Engineering: Responsible for ensuring that the equipment is installed according to specifications.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation of Fitz Mill / Comminuting Mill.
- Availability of qualified personnel for testing.
Equipment Description
The Fitz Mill / Comminuting Mill is a high-speed size reduction machine designed for the milling of solid dosage forms. It operates by using a rotating blade to reduce particle size, ensuring uniformity and consistency in the final product.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify speed settings and screen PSD. | Speed settings must match specifications; screen PSD must align with URS. | Calibration records, test results. |
Detailed Test Cases
Test Case T1: Speed and Screen PSD Verification
Objective: To verify that the Fitz Mill operates at the specified speed and produces the required particle size distribution (PSD).
Procedure: Adjust the mill to the specified speed settings and conduct a milling operation. Collect samples for PSD analysis.
Acceptance Criteria: Speed must be within ±10% of specified settings; PSD must meet the criteria outlined in the URS.
Evidence: Record of speed settings, PSD analysis reports, and operator logs.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A root cause analysis will be performed, and corrective actions will be implemented as necessary.
Approvals
Approved By: [Name] – [Title]
Date: [Date]
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