Document Control
Document Number: IQ-FM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Fitz Mill / Comminuting Mill
Objective: To verify that the Fitz Mill / Comminuting Mill is installed according to manufacturer specifications and meets the requirements outlined in the User Requirement Specification (URS).
Scope: This protocol applies to the Installation Qualification of the Fitz Mill / Comminuting Mill used for size reduction in the production area of solid dosage forms.
Responsibilities:
- Validation Team: Ensure the protocol is executed and documented accurately.
- Engineering: Responsible for equipment installation and initial setup.
- Quality Assurance: Review and approve the IQ protocol and results.
Prerequisites:
- Completion of equipment installation by engineering.
- Availability of all necessary documentation, including URS and manufacturer’s specifications.
- Training of personnel on the operation of the Fitz Mill.
Equipment Description:
The Fitz Mill / Comminuting Mill is a size reduction machine designed for processing solid dosage forms. It utilizes a high-speed rotating blade to achieve desired particle size distribution (PSD) through various screen sizes.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-FM-01 | Verify installation against manufacturer’s specifications. | All components installed as per specifications. | Installation checklist signed off. |
| IQ-FM-02 | Check alignment and leveling of the equipment. | Equipment is level and aligned according to specifications. | Leveling report. |
| IQ-FM-03 | Test speed settings of the mill. | Speed settings within specified range. | Speed test results log. |
| IQ-FM-04 | Verify screen size and PSD. | PSD matches specified parameters in URS. | PSD analysis report. |
Detailed Test Cases:
Test Case 1: Installation Verification
Objective: Ensure all components are installed as per manufacturer’s specifications.
Procedure: Cross-check installed components with the installation manual.
Acceptance Criteria: All components must be present and correctly installed.
Evidence: Installation checklist signed by the responsible engineer.
Test Case 2: Equipment Leveling
Objective: Confirm that the Fitz Mill is level and properly aligned.
Procedure: Use a leveling tool to check the equipment’s alignment.
Acceptance Criteria: The equipment must be level within ±0.5 degrees.
Evidence: Leveling report documenting the measurements.
Test Case 3: Speed Settings
Objective: Validate that the speed settings are operational and within specified limits.
Procedure: Operate the mill at various speed settings and measure actual speeds.
Acceptance Criteria: Speed settings must be within ±10% of specified values.
Evidence: Speed test results log with recorded speeds.
Test Case 4: Particle Size Distribution (PSD)
Objective: Assess the PSD after milling to ensure it meets specifications.
Procedure: Collect samples post-milling and conduct PSD analysis.
Acceptance Criteria: PSD must match specifications outlined in the URS.
Evidence: PSD analysis report detailing results.
Deviations:
Any deviations from the acceptance criteria must be documented, investigated, and approved by Quality Assurance before proceeding with further validation activities.
Approvals:
Prepared By: ____________________ Date: ____________
Approved By: ____________________ Date: ____________