Document Control
Document Number: OQ-CHK-001
Revision: 1.0
Effective Date: 2023-10-01
Prepared By: [Your Name]
Approved By: [Approver Name]
Operational Qualification Protocol for Checkweigher in Suppository Packaging
Meta Description: Operational Qualification (OQ) protocol for Checkweigher used in the packaging of suppositories, ensuring weight accuracy and compliance with URS Annex11.
Objective
The objective of this Operational Qualification (OQ) protocol is to verify the weight accuracy of the checkweigher used in the packaging of suppositories, ensuring compliance with established acceptance criteria and regulatory standards.
Scope
This protocol applies to the checkweigher located in the packaging area, specifically for the verification of suppository weights during production. It encompasses all relevant procedures and documentation related to the OQ of this equipment.
Responsibilities
Validation Team: Responsible for executing the OQ protocol and documenting results.
Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
Production Team: Responsible for operating the checkweigher and ensuring compliance with the protocol during testing.
Prerequisites
Ensure that the checkweigher is installed, calibrated, and operational prior to conducting the OQ. All personnel involved must be trained on the equipment and the OQ protocol.
Equipment Description
The checkweigher is an automated device used to verify the weight of suppositories during the packaging process. It features weight accuracy reject logic, audit trail logs, and is critical for ensuring product quality and compliance.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-CHK-001-01 | Verify weight accuracy using calibrated weights. | Must pass within ±5% of target weight. | Calibration records, test results. |
| OQ-CHK-001-02 | Audit trail log verification. | Log must show no discrepancies for 30 days. | Audit trail report. |
Detailed Test Cases
Test Case OQ-CHK-001-01
Objective: To verify the weight accuracy of the checkweigher.
Procedure: Use calibrated weights to test the checkweigher. Record the weight readings.
Acceptance Criteria: Must pass within ±5% of target weight.
Expected Results: All readings must be within the specified range.
Test Case OQ-CHK-001-02
Objective: To verify the integrity of the audit trail logs.
Procedure: Review audit trail logs for the past 30 days.
Acceptance Criteria: Log must show no discrepancies.
Expected Results: Audit trail must be complete and accurate.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. Appropriate corrective actions should be taken to address any issues identified during testing.
Approvals
By signing below, the undersigned confirm that they have reviewed and approved this Operational Qualification protocol.
Prepared By: ________________________
Date: ________________________
Approved By: ________________________
Date: ________________________
Data Integrity Checks
1. Ensure that all weight readings are automatically logged with timestamps.
2. Verify that any weight rejections are recorded in the audit trail.
3. Confirm that user access to the checkweigher is restricted to authorized personnel only.