Document Number: IQ-OG-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Oscillating Granulator
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Oscillating Granulator is installed correctly and operates according to the specified requirements, ensuring compliance with industry standards and regulatory requirements.
Scope
This protocol applies to the Installation Qualification of the Oscillating Granulator used in the production of solid dosage forms within the milling area.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and addressing any deviations. The Quality Assurance team is responsible for reviewing and approving the protocol and results.
Prerequisites
- Equipment must be delivered and installed as per manufacturer’s specifications.
- Utilities (power, water, etc.) must be operational.
- Personnel must be trained on equipment operation.
Equipment Description
The Oscillating Granulator is designed for size reduction of wet and dry mass, ensuring a uniform particle size distribution. Key critical parameters include speed, screen size, and output particle size distribution (PSD).
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation against manufacturer’s specifications. | All components installed per specifications. | Installation checklist completed. |
| IQ-02 | Check utility connections (power, water). | All utilities operational. | Utility check report. |
| IQ-03 | Calibrate speed settings. | Speed settings within specified range. | Calibration report. |
| IQ-04 | Check screen size installation. | Screen size matches specifications. | Screen size verification report. |
| IQ-05 | Perform initial output PSD analysis. | Output PSD within defined limits. | PSD analysis report. |
Detailed Test Cases
Test Case IQ-01
Objective: Verify installation against manufacturer’s specifications.
Procedure: Inspect each component and compare with the installation manual.
Acceptance Criteria: All components installed per specifications.
Evidence: Installation checklist completed and signed off.
Test Case IQ-02
Objective: Check utility connections (power, water).
Procedure: Inspect utility connections and perform functionality tests.
Acceptance Criteria: All utilities operational.
Evidence: Utility check report signed by responsible personnel.
Test Case IQ-03
Objective: Calibrate speed settings.
Procedure: Use a calibrated tachometer to verify speed settings.
Acceptance Criteria: Speed settings within specified range.
Evidence: Calibration report documenting results.
Test Case IQ-04
Objective: Check screen size installation.
Procedure: Measure screen size using calipers.
Acceptance Criteria: Screen size matches specifications.
Evidence: Screen size verification report.
Test Case IQ-05
Objective: Perform initial output PSD analysis.
Procedure: Collect samples and analyze particle size distribution.
Acceptance Criteria: Output PSD within defined limits.
Evidence: PSD analysis report with results documented.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions implemented as necessary.
Approvals
Prepared By: ______________________ Date: ____________
Approved By: ______________________ Date: ____________