Document ID: OQ-EXT-001
Version: 1.0
Date: 2023-10-01
Prepared by: Validation Team
Approved by: QA Manager
Operational Qualification Protocol for Single Screw Extruder in Solid Dosage Form Production
Objective: To validate the operational performance of the Single Screw Extruder to ensure it meets the specified requirements for the production of pellets.
Scope: This protocol covers the operational qualification of the Single Screw Extruder used in the production area for Solid Dosage Forms (OSD), specifically for the extrusion of pellets.
Responsibilities:
- Validation Team: Preparation and execution of the OQ protocol.
- QA Team: Review and approval of the OQ protocol.
- Production Team: Operation of the equipment during testing.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- Operator training on the Single Screw Extruder.
- Availability of necessary materials and resources for testing.
Equipment Description:
The Single Screw Extruder is designed for the extrusion of pellets in solid dosage forms. It operates by converting raw materials into a homogenous mixture through mechanical and thermal processes. Key critical parameters include screw speed, feed rate, and torque.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Measure screw speed at various settings. | Within specified range as per URS Annex11. | Calibration records and measurement logs. |
| OQ-02 | Measure feed rate during operation. | Consistent with URS Annex11 requirements. | Feed rate logs and calibration data. |
| OQ-03 | Monitor torque during extrusion. | Torque levels must remain within specified limits. | Torque measurement reports. |
Detailed Test Cases:
- Test Case OQ-01: Verify screw speed settings at low, medium, and high levels. Document the readings and ensure compliance with URS Annex11.
- Test Case OQ-02: Conduct feed rate tests using standard raw materials. Compare results against acceptance criteria outlined in URS Annex11.
- Test Case OQ-03: Record torque values during continuous operation for a set period. Ensure values do not exceed defined thresholds.
Deviations: Any deviations from the acceptance criteria must be documented and justified. Investigate the root cause, and implement corrective actions as necessary.
Approvals:
- ____________________ (Validation Team)
- ____________________ (QA Manager)
Data Integrity Checks:
- Ensure all data collected during testing is logged in a secure electronic system.
- Perform regular backups of data to prevent loss.
- Implement audit trails to track changes in data records.