Document Control Number: IQ-LM-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Reviewer Name]
Approval Date: [Insert Approval Date]
Installation Qualification Protocol for Labeling Machine
Objective: To ensure that the Labeling Machine is installed correctly and operates according to predefined specifications, ensuring compliance with regulatory requirements.
Scope: This protocol applies to the Installation Qualification of the Labeling Machine used in the packaging area for the application of labels on suppositories and implants.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
- Maintenance Team: Responsible for installation and maintenance of the equipment.
Prerequisites:
- Completion of equipment installation as per manufacturer’s guidelines.
- Availability of necessary documentation (URS, design specifications, etc.).
- Training of personnel on equipment operation.
Equipment Description: The Labeling Machine is designed to apply labels to suppositories and implants with a focus on placement accuracy. It features an audit trail log for tracking placement accuracy.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation according to manufacturer’s specifications. | All components installed as per specifications. | Installation checklist signed off. |
| IQ-02 | Check placement accuracy of labels. | Placement accuracy within ±1mm. | Audit trail logs. |
| IQ-03 | Review data integrity checks. | All logs show no gaps or anomalies. | Data integrity report. |
Detailed Test Cases:
- Test Case IQ-01: Inspect all components of the Labeling Machine to confirm they are installed as per the manufacturer’s specifications. Document any discrepancies.
- Test Case IQ-02: Conduct a placement accuracy test by applying labels to a batch of test products and measuring the placement. Log the results in the audit trail.
- Test Case IQ-03: Perform a review of the audit trail logs to ensure there are no gaps or anomalies that could indicate data integrity issues.
Deviations: Any deviations from the acceptance criteria must be documented and addressed according to the deviation management procedure.
Approvals:
- Validation Team Lead: ___________________ Date: ____________
- Quality Assurance Manager: ______________ Date: ____________