Document Control Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Coding/Printing Machine in Ophthalmics
Meta Description: This document outlines the Design Qualification Protocol for a Coding/Printing Machine used in the packaging of sterile eye drops and ointments, ensuring compliance with validation standards.
Tags: Equipment Validation, Design Qualification, Ophthalmics, Coding Machine, Packaging
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Coding/Printing Machine used for printing batch and expiry information on sterile eye drops and ointments meets the required specifications and regulatory standards.
Scope
This protocol applies to the Coding/Printing Machine located in the Packaging area for ophthalmic products, specifically sterile eye drops and ointments. It covers the validation of equipment critical to product quality and compliance.
Responsibilities
- Validation Team: Responsible for the execution and documentation of the DQ protocol.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol.
- Engineering: Responsible for maintaining the Coding/Printing Machine and addressing any technical issues.
Prerequisites
- Completion of User Requirements Specification (URS) as per Annex 11.
- Installation Qualification (IQ) of the Coding/Printing Machine.
- Training of personnel on equipment operation and validation procedures.
Equipment Description
The Coding/Printing Machine is designed for printing batch and expiry dates on packaging for sterile eye drops and ointments. It ensures high print quality and compliance with regulatory standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Print Quality Verification Audit Trail | Audit trail must show no discrepancies in print quality. | Audit trail report and print samples. |
Detailed Test Cases
Test Case 1: Print Quality Verification
Objective: Verify the print quality and ensure it meets specifications.
Procedure: Conduct a print quality check on 10 sample outputs.
Acceptance Criteria: All samples must have clear, legible print with no smudging or fading.
Evidence: Photographic evidence of samples and audit trail report.
Test Case 2: Audit Trail Review
Objective: Ensure the audit trail accurately reflects all print operations.
Procedure: Review the audit trail for the last 30 print runs.
Acceptance Criteria: No missing entries and all entries must be time-stamped.
Evidence: Printed audit trail report.
Deviations
Any deviations from the acceptance criteria must be documented and assessed. A corrective action plan must be developed to address any issues identified during testing.
Approvals
All sections of this Design Qualification Protocol must be reviewed and approved by the Quality Assurance and Validation Team before implementation.