Document Control Number: DQ-CHK-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Inline Checkweigher in Ophthalmics
Meta Description: This document outlines the Design Qualification protocol for the inline checkweigher used in the packaging of sterile eye drops and ointments, ensuring compliance with critical acceptance criteria.
Tags: Equipment Validation, Design Qualification, Checkweigher, Ophthalmics
Objective
The objective of this Design Qualification (DQ) protocol is to verify that the inline checkweigher used in the packaging of sterile eye drops and ointments meets all specified requirements and operates within defined acceptance criteria.
Scope
This protocol applies to the inline checkweigher utilized in the packaging area for the verification of fill weight for sterile eye drops and ointments. It encompasses the validation of the equipment’s performance and compliance with regulatory requirements.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Engineering: Responsible for ensuring the equipment is installed and maintained according to specifications.
Prerequisites
- Installation of the inline checkweigher must be completed.
- All relevant Standard Operating Procedures (SOPs) must be in place.
- Personnel must be trained on equipment operation and validation procedures.
Equipment Description
The inline checkweigher is designed to accurately measure the weight of filled containers of sterile eye drops and ointments during the packaging process. It features an accuracy reject logic and an audit trail for compliance tracking.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-CHK-001 | Verify accuracy of the checkweigher using calibrated weights. | Must meet ±0.5g of target weight. | Calibration report and weight test results. |
| DQ-CHK-002 | Audit trail verification of reject logic. | Audit trail must record all weight rejects. | Audit trail log report. |
Detailed Test Cases
Test Case 1: Accuracy Verification
Procedure: Use calibrated weights to test the checkweigher’s accuracy. Record the weight measurement for each test weight.
Acceptance Criteria: Weight measurements must be within ±0.5g of the target weight.
Evidence: Calibration report and recorded weight measurements.
Test Case 2: Reject Logic Audit Trail
Procedure: Simulate weight rejects by placing weights outside the acceptance range and verify the audit trail logs.
Acceptance Criteria: The audit trail must accurately log each rejected weight.
Evidence: Audit trail report showing all reject entries.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be developed for any significant deviations.
Approvals
Approved By: ______________________
Date: ______________________
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