Document Control
Document ID: DQ-PCS-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Coding Machines in Packaging
Objective: To establish a Design Qualification (DQ) protocol for the Coding Machine (Laser / Inkjet) used for printing batch and expiry information on prefilled syringes and cartridges, ensuring compliance with regulatory requirements and operational excellence.
Scope: This protocol applies to the Coding Machine utilized in the packaging area for prefilled syringes and cartridges, ensuring direct product impact and adherence to critical validation requirements.
Responsibilities:
- Validation Team: Execute and document qualification activities.
- Quality Assurance: Review and approve the DQ protocol and results.
- Operations: Ensure the equipment is maintained and operated according to validated procedures.
Prerequisites:
- Completion of User Requirements Specification (URS) Annex 11.
- Installation Qualification (IQ) completion.
- Training of personnel on equipment operation and validation procedures.
Equipment Description:
The Coding Machine (Laser / Inkjet) is designed to print batch and expiry dates on prefilled syringes and cartridges. It ensures high print quality and maintains an audit trail for compliance purposes.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T001 | Verify print quality and clarity. | Print quality meets specifications outlined in URS Annex 11. | Print samples and quality audit logs. |
| T002 | Check audit trail functionality. | Audit trail logs are complete and retrievable. | Audit trail log report. |
Detailed Test Cases:
Test Case T001:
- Procedure: Print a sample batch and expiry date on a prefilled syringe.
- Acceptance Criteria: The printed information must be legible, accurate, and conform to URS specifications.
- Evidence: Capture images of printed syringes and maintain a record of print quality assessments.
Test Case T002:
- Procedure: Generate an audit trail report after printing.
- Acceptance Criteria: The report should include all print jobs with timestamps and operator details.
- Evidence: Save the audit trail report in the validation documentation.
Deviations:
Any deviations observed during testing must be documented and reviewed by the Validation Team and Quality Assurance. A corrective action plan will be initiated to address any critical issues.
Approvals:
Approved By: ______________________
Title: _____________________________
Date: ______________________________