Operational Qualification Protocol for Loss-in-Weight Feeder in Continuous Manufacturing
Document Control:
Document Number: OQ-001
Revision: 1.0
Date: 2023-10-01
Prepared by: Validation Team
Approved by: Quality Assurance
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Loss-in-Weight Feeder operates within predetermined specifications and meets the requirements outlined in the User Requirement Specification (URS) Annex 11.
Scope
This protocol applies to the Loss-in-Weight Feeder used in the production area for continuous manufacturing of solid dosage forms, focusing on its ability to accurately feed powders.
Responsibilities
- Validation Team: Prepare and execute the OQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide necessary access and support during testing.
Prerequisites
- Loss-in-Weight Feeder installation must be complete.
- All relevant personnel must be trained on equipment operation.
- Calibration and maintenance records must be up to date.
Equipment Description
The Loss-in-Weight Feeder is designed for accurate powder feeding in continuous manufacturing processes. It utilizes a control loop to monitor and adjust the feed rate, ensuring precise delivery of materials.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify feed accuracy control loop alarms. | Alarms activate within specified limits. | Alarm log report. |
| OQ-02 | Check feed rate accuracy under various loads. | Accuracy within ±5% of target rate. | Feed rate test results. |
Detailed Test Cases
Test Case OQ-01: Verify Feed Accuracy Control Loop Alarms
Objective: Ensure that the control loop alarms function correctly.
Procedure: Simulate conditions that would trigger alarms and verify activation.
Acceptance Criteria: Alarms must activate within specified limits as per URS Annex 11.
Evidence: Document alarm log report showing alarm activation.
Test Case OQ-02: Check Feed Rate Accuracy Under Various Loads
Objective: Validate that the feed rate is accurate across different load conditions.
Procedure: Measure feed rate at various predefined loads and compare against target.
Acceptance Criteria: Feed rate accuracy must be within ±5% of target rate.
Evidence: Provide feed rate test results documentation.
Data Integrity Checks
As CSV is required, the following data integrity checks will be implemented:
- Ensure all data entries are timestamped and attributed to the responsible personnel.
- Verify that all test results are backed up and stored securely.
- Conduct periodic audits to ensure data consistency and accuracy.
Deviations
Any deviations from the protocol must be documented and reviewed by the Quality Assurance team. Appropriate corrective actions will be determined based on the nature of the deviation.
Approvals
Prepared by: ______________________
Date: ______________________
Approved by: ______________________
Date: ______________________