Document Number: DQ-CHK-001
Version: 1.0
Effective Date: 2023-10-01
Prepared By: [Your Name]
Reviewed By: [Reviewer Name]
Approved By: [Approver Name]
Design Qualification Protocol for Checkweigher Used in Suppository Packaging
Objective: To establish and document the qualification of the checkweigher to ensure it meets the requirements for verifying the weight of suppositories.
Scope: This protocol applies to the checkweigher used in the packaging area for the direct measurement of suppository weights. It covers the validation process including installation, operational, and performance qualifications.
Responsibilities:
- Validation Team: Responsible for executing the validation protocol.
- Quality Assurance: Responsible for reviewing and approving the protocol.
- Engineering: Responsible for equipment maintenance and support.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on checkweigher operations.
- Availability of required documentation and specifications.
Equipment Description: The checkweigher is an automated device used to measure the weight of individual suppository units during the packaging process. The equipment features weight accuracy reject logic and maintains an audit trail of logs for compliance and traceability.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-CHK-001-01 | Verify weight accuracy using standard weights. | Weight accuracy within ±0.1g of specified target. | Calibration certificate and test results. |
| DQ-CHK-001-02 | Check reject logic functionality. | Reject logic activates for weights outside acceptance criteria. | Log of rejected units during testing. |
| DQ-CHK-001-03 | Review audit trail logs for completeness. | Audit trail logs are complete and accurate. | Extracted audit trail logs. |
Detailed Test Cases:
- Weight Accuracy Test:
Using calibrated weights, perform tests on the checkweigher to ensure it measures within the specified tolerance.
- Reject Logic Test:
Simulate weights above and below the acceptance criteria to verify the reject mechanism functions correctly.
- Audit Trail Review:
Extract and review the audit logs to ensure that all operations are recorded accurately and completely.
Deviations: Any deviations from the acceptance criteria or procedures must be documented, investigated, and resolved before final approval of the qualification.
Approvals:
- Prepared By: ________________________ Date: __________
- Reviewed By: ________________________ Date: __________
- Approved By: ________________________ Date: __________
Data Integrity Checks:
- Ensure all data entries are time-stamped and attributed to the responsible operator.
- Perform periodic reviews of audit logs to confirm no unauthorized changes.
- Implement backup procedures for all data collected during the validation process.