Document Number: IQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Rotary Sifter
Objective: To verify that the Rotary Sifter is installed correctly and operates according to specified requirements.
Scope: This protocol applies to the Installation Qualification of the Rotary Sifter used in the production of Solid Dosage Forms.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol.
- Quality Assurance: Responsible for reviewing and approving the protocol.
- Engineering: Responsible for the installation of the equipment.
Prerequisites:
- Completion of equipment installation.
- Availability of relevant documentation (URS, specifications).
- Training of personnel on the operation of the Rotary Sifter.
Equipment Description:
The Rotary Sifter is designed for sifting powders in the production of Solid Dosage Forms. It features adjustable speed settings and screen integrity monitoring to ensure product quality.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation per manufacturer’s specifications. | Installation meets all specified requirements. | Installation checklist signed off by Engineering. |
| IQ-02 | Check speed settings functionality. | Speed settings operate within specified range. | Calibration report for speed settings. |
| IQ-03 | Inspect screen integrity. | No visible damage or defects in the screen. | Visual inspection report. |
Detailed Test Cases:
- Test Case IQ-01: Ensure that the Rotary Sifter is installed according to the manufacturer’s specifications. Document any discrepancies.
- Test Case IQ-02: Adjust the speed settings to the required levels and verify that the equipment responds accurately. Document the results.
- Test Case IQ-03: Conduct a visual inspection of the sifter screen to confirm its integrity. Document any findings.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on equipment performance and product quality.
Approvals:
- Prepared By: [Insert Name]
- Reviewed By: [Insert Name]
- Approved By: [Insert Name]