Checkweigher (Inline) – IQ Protocol

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.

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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: ___________

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