Document ID: DQ-LM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Design Qualification Protocol for Labeling Machine in Packaging of Suppositories & Implants
Objective: To establish a Design Qualification (DQ) protocol for the validation of the labeling machine used in the packaging of suppositories and implants, ensuring compliance with regulatory requirements and product quality standards.
Scope: This protocol applies to the labeling machine utilized in the packaging area for the application of labels on suppositories and implants, impacting product quality directly.
Responsibilities:
- Validation Team: Prepare and execute the DQ protocol.
- Quality Assurance: Review and approve the DQ protocol and results.
- Maintenance Team: Ensure the labeling machine is maintained in accordance with the manufacturer’s specifications.
Prerequisites:
- Completion of User Requirements Specification (URS) per Annex 11.
- Installation Qualification (IQ) of the labeling machine.
- Training of personnel on the operation of the labeling machine.
Equipment Description:
The labeling machine is designed to apply labels accurately on suppositories and implants within the packaging area. It features an automated system for label placement and includes an audit trail log for placement accuracy.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify placement accuracy of labels on test suppositories. | Labels are placed within ±1mm of the specified location. | Audit trail logs, photographic evidence. |
| T2 | Check the functionality of the audit trail log. | Audit trail logs must record all placements accurately. | Log review report. |
Detailed Test Cases:
- Test Case T1: Conduct a placement accuracy test using 10 sample suppositories. Measure the distance from the specified placement point to the actual label position. Document findings in the audit trail log.
- Test Case T2: Perform a thorough check of the labeling machine’s audit trail function. Ensure all label placements are logged with timestamps and operator identification.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed. Investigate the root cause and implement corrective actions as necessary.
Approvals:
- Prepared by: _______________________ Date: ___________
- Reviewed by: _______________________ Date: ___________
- Approved by: _______________________ Date: ___________
Data Integrity Checks:
- Regular backups of audit trail logs.
- Access controls to prevent unauthorized changes to the labeling machine settings and logs.
- Periodic review of audit logs to ensure compliance with placement accuracy standards.