Installation Qualification Protocol for Inline Checkweigher in Ophthalmics
Document Control
Document ID: IQ-CHK-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Objective
To verify that the Inline Checkweigher is installed correctly and operates according to specified requirements in the packaging of sterile eye drops and eye ointments.
Scope
This protocol applies to the Installation Qualification of the Inline Checkweigher used in the packaging area for ophthalmic products.
Responsibilities
The Validation Team is responsible for executing this protocol. The Quality Assurance Team will review and approve the results.
Prerequisites
All necessary documentation, including user manuals, installation guides, and URS Annex11 must be available prior to execution of this protocol.
Equipment Description
The Inline Checkweigher is designed to verify the fill weight of sterile eye drops and eye ointments during the packaging process. The equipment is equipped with accuracy reject logic and an audit trail feature.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-CHK-001 | Verify installation of the checkweigher according to manufacturer’s specifications. | Installation matches the specifications outlined in the user manual. | Installation checklist signed by the technician. |
| IQ-CHK-002 | Conduct accuracy tests using calibrated weights. | Weight measurements within ±0.5g of the target weight. | Calibration report and test results. |
| IQ-CHK-003 | Audit trail functionality test. | Audit trail logs all actions performed on the checkweigher. | Audit trail report. |
Detailed Test Cases
Test Case: IQ-CHK-001
Objective: Verify that the Inline Checkweigher is installed according to the manufacturer’s specifications.
Procedure: Review the installation checklist against the manufacturer’s specifications.
Acceptance: Installation matches specifications.
Evidence: Installation checklist signed by the technician.
Test Case: IQ-CHK-002
Objective: Verify the accuracy of the checkweigher.
Procedure: Use calibrated weights to perform accuracy tests.
Acceptance: Measurements within ±0.5g of target weight.
Evidence: Calibration report and test results.
Test Case: IQ-CHK-003
Objective: Verify the functionality of the audit trail.
Procedure: Perform actions on the checkweigher and review the audit trail.
Acceptance: Audit trail logs all actions performed.
Evidence: Audit trail report.
Deviations
Any deviations from the protocol must be documented and approved by the Quality Assurance Team.
Approvals
__________________________
Validation Team Lead
Date: ___________
__________________________
Quality Assurance Manager
Date: ___________