Operational Qualification Protocol for RMG in Solid Dosage Form Production
Document Number: OQ-RMG-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Objective
The objective of this protocol is to establish the operational qualification of the Rapid Mixer Granulator (RMG) used in the production of solid dosage forms, ensuring it meets predefined acceptance criteria and operates within specified limits.
Scope
This protocol applies to the Rapid Mixer Granulator located in the Production/Granulation area for wet granulation processes. It covers equipment validation, critical parameters, and acceptance criteria referenced in the URS Annex11.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for operating the equipment according to the protocol.
Prerequisites
- Completion of Installation Qualification (IQ) for the Rapid Mixer Granulator.
- All relevant personnel trained on equipment operation.
- Availability of necessary materials for testing.
Equipment Description
The Rapid Mixer Granulator (RMG) is designed for wet granulation processes. It features adjustable impeller and chopper speeds, torque monitoring, and a PLC system for operational control. The equipment is critical for ensuring product quality in solid dosage forms.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-01 | Verify Impeller Speed | Within specified range (e.g., 50-150 RPM) | Calibration report |
| OQ-02 | Verify Chopper Speed | Within specified range (e.g., 100-300 RPM) | Calibration report |
| OQ-03 | Check Torque Monitoring | Torque within acceptable limits | Torque data logs |
| OQ-04 | Test PLC Alarms | All alarms function correctly | Alarm test results |
Detailed Test Cases
Test Case OQ-01: Verify Impeller Speed
Objective: To confirm that the impeller speed is adjustable and operates within the specified range.
Procedure: Set the impeller speed to various levels within the range and record the actual speed.
Acceptance Criteria: The recorded speeds must be within the specified limits.
Evidence: Calibration report showing speed measurements.
Test Case OQ-02: Verify Chopper Speed
Objective: To ensure the chopper speed is adjustable and operates within the specified range.
Procedure: Set the chopper speed to various levels within the range and record the actual speed.
Acceptance Criteria: The recorded speeds must be within the specified limits.
Evidence: Calibration report showing speed measurements.
Test Case OQ-03: Check Torque Monitoring
Objective: To verify that the torque monitoring system is functioning correctly.
Procedure: Observe torque readings during operation and compare with expected values.
Acceptance Criteria: Torque must remain within acceptable limits throughout operation.
Evidence: Torque data logs.
Test Case OQ-04: Test PLC Alarms
Objective: To confirm that all PLC alarms activate appropriately during fault conditions.
Procedure: Simulate fault conditions and verify alarm activation.
Acceptance Criteria: All alarms must function as intended.
Evidence: Alarm test results documentation.
Deviations
Any deviations from the protocol must be documented and approved by Quality Assurance prior to proceeding with the test.
Approvals
Prepared By: [Your Name]
Approved By: [Approver’s Name]
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