Document Control:
- Document Number: OQ-001
- Version: 1.0
- Effective Date: 2023-10-01
- Review Date: 2024-10-01
- Approved By: [Name]
Operational Qualification Protocol for Inline Tablet Checkweigher
Objective: To validate the operational performance of the Inline Tablet Checkweigher used for weight verification in the production of solid dosage forms.
Scope: This protocol applies to the Inline Tablet Checkweigher located in the Production/Compression area for direct product impact with criticality classified as critical.
Responsibilities:
- Validation Team: Execute and document the qualification activities.
- Quality Assurance: Review and approve the protocol and results.
- Operations: Provide access to the equipment and necessary resources.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of operational procedures for the equipment.
- Training of personnel on equipment usage and data handling.
Equipment Description: The Inline Tablet Checkweigher is designed for real-time weight verification of tablets during the production process. It features an accuracy reject mechanism and maintains an audit trail for compliance and traceability.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify accuracy of weight measurements using calibrated weights. | Weight measurements must be within ±5% of the target weight. | Calibration certificates and measurement logs. |
| OQ-02 | Audit trail review for reject mechanism. | Audit trail must show all rejected weights and actions taken. | Audit trail report. |
Detailed Test Cases:
- Test Case OQ-01: Use calibrated weights to check the accuracy of the tablet checkweigher. Record the weights and compare against the target.
- Test Case OQ-02: Review the audit trail for the reject mechanism to ensure all actions are documented and compliant with URS Annex11.
Deviations: Any deviations from the acceptance criteria must be documented, with a thorough investigation conducted to determine the root cause and corrective actions taken.
Data Integrity Checks:
- Ensure that all weight measurements are automatically logged with timestamps.
- Verify the integrity of the audit trail by checking for unauthorized access or modifications.
- Conduct regular backups of all data to prevent loss.
Approvals:
- Validation Team Lead: ______________________ Date: __________
- Quality Assurance: ______________________ Date: __________
- Operations Manager: ______________________ Date: __________