Operational Qualification Protocol for High Shear Granulator in Solid Dosage Form
Document ID: OQ-HSG-001
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Insert Name]
Reviewed by: [Insert Name]
Approved by: [Insert Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the High Shear Granulator (HSG) operates according to specified requirements and meets the acceptance criteria for wet granulation processes.
Scope
This protocol applies to the High Shear Granulator (HSG) used in the Production/Granulation area for the direct impact on product quality in solid dosage forms.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting the results, and ensuring compliance with regulatory requirements. The Quality Assurance (QA) team will review and approve the documentation.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- All personnel involved must be trained on the equipment and procedures.
- All required materials and supplies must be available.
Equipment Description
The High Shear Granulator (HSG) is designed for wet granulation processes within the production of solid dosage forms. Key features include adjustable speed, torque control, and a programmable logic controller (PLC) for precise operation.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-HSG-01 | Verify speed settings at various levels. | Speed within ±10% of set point. | Calibration records. |
| OQ-HSG-02 | Measure time taken for granulation. | Time within specified limits. | Time logs. |
| OQ-HSG-03 | Monitor torque during operation. | Torque within specified range. | Torque readings. |
| OQ-HSG-04 | Confirm binder addition accuracy. | Binder addition within ±5% of target. | Binder addition logs. |
| OQ-HSG-05 | Validate PLC functionality. | PLC operates without errors. | PLC test reports. |
Detailed Test Cases
Test Case OQ-HSG-01
Procedure: Adjust the speed settings of the HSG to the specified levels and record the actual speed.
Acceptance Criteria: Speed must be within ±10% of the set point.
Evidence: Calibration records must be maintained.
Test Case OQ-HSG-02
Procedure: Start the granulation process and measure the time taken to complete.
Acceptance Criteria: Time taken must be within the specified limits.
Evidence: Time logs must be documented.
Test Case OQ-HSG-03
Procedure: Monitor the torque during the granulation process and record the values.
Acceptance Criteria: Torque must remain within the specified range.
Evidence: Torque readings must be collected.
Test Case OQ-HSG-04
Procedure: Add binder to the granulation mixture and verify the amount added.
Acceptance Criteria: Binder addition must be within ±5% of the target amount.
Evidence: Binder addition logs must be maintained.
Test Case OQ-HSG-05
Procedure: Perform a functional test of the PLC to ensure it operates as expected.
Acceptance Criteria: PLC must operate without errors during the test.
Evidence: PLC test reports must be documented.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be implemented.
Approvals
This protocol must be approved by the following individuals:
- Validation Manager: _________________________
- Quality Assurance Representative: _________________________
- Production Manager: _________________________