Coding Machine (Inkjet/Laser) – DQ Protocol

Document Number: DQ-001

Version: 1.0

Date: 2023-10-01

Prepared by: [Your Name]

Approved by: [Approver’s Name]

Design Qualification Protocol for Coding Machine in Nasal and Otic Product Packaging

Objective: To establish the Design Qualification (DQ) for the Coding Machine used for printing batch and expiry information on Nasal and Otic products, ensuring compliance with regulatory requirements.

Scope: This protocol applies to the Coding Machine (Inkjet/Laser) utilized in the packaging area for both sterile and non-sterile nasal and otic products.

Responsibilities:

  • Validation Team: Responsible for executing the DQ protocol and documenting results.
  • Quality Assurance: Review and approve the DQ protocol and results.
  • Engineering: Ensure the Coding Machine is installed and functioning as specified.

Prerequisites:

  • Installation Qualification (IQ) completed.
  • Operational Qualification (OQ) completed.
  • Training of personnel on equipment operation.

Equipment Description:

The Coding Machine is an Inkjet/Laser printer designed for printing batch and expiry dates on packaging materials for nasal and otic products. It is critical to ensure the print quality and audit trail logs are maintained for compliance.

Test ID Procedure Acceptance Criteria Evidence
T1 Verify print quality using test prints. Prints must be clear and legible. Test print samples and logs.
T2 Check audit trail logs for print jobs. Logs must show all print jobs with timestamps. Audit trail log reports.

Detailed Test Cases:

Test Case T1:

  • Objective: Ensure print quality meets specifications.
  • Procedure: Print a series of test labels and inspect for clarity.
  • Acceptance Criteria: All printed labels must be readable without smudges or errors.
  • Evidence: Capture images of printed labels and document findings.
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Test Case T2:

  • Objective: Verify that the audit trail logs are complete and accurate.
  • Procedure: Review audit trail logs for the last 30 print jobs.
  • Acceptance Criteria: All entries must include date, time, and operator ID.
  • Evidence: Printout of audit trail logs and any discrepancies noted.

Deviations:

Any deviations from the acceptance criteria must be documented, along with the rationale and corrective actions taken.

Approvals:

Prepared by: ___________________ Date: ___________

Approved by: ___________________ Date: ___________

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