Document Control
Document Number: DQ-CPM-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Coding/Printing Machine in IV Infusions
Meta Description: This document outlines the Design Qualification Protocol for the Coding/Printing Machine used in IV Infusions, ensuring compliance with regulatory standards.
Tags: Design Qualification, Equipment Validation, IV Infusions, Coding Machine, Pharmaceutical Validation
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Coding/Printing Machine (Inkjet/Laser) used for printing batch and expiry information on IV infusion bags and bottles meets the specified requirements and performs consistently and reliably in a validated state.
Scope
This protocol applies to the Coding/Printing Machine utilized in the Packaging/Primary area for IV Infusions (LVP/SVP – Bags/Bottles). It covers the validation process to ensure direct product impact with criticality classified as critical.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol.
- Operations: Responsible for providing operational input and ensuring equipment readiness.
Prerequisites
- Completion of User Requirement Specification (URS) Annex 11.
- Installation Qualification (IQ) completed.
- Operational Qualification (OQ) completed.
Equipment Description
The Coding/Printing Machine is designed for high-speed printing of batch and expiry dates on IV infusion bags and bottles. It utilizes either inkjet or laser technology to ensure print quality and reliability.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Print Quality Verification | Print must be clear, legible, and within specified tolerances. | Print samples and audit trail records. |
| T2 | Audit Trail Verification | All print jobs must be logged with timestamps and user IDs. | Audit trail report. |
Detailed Test Cases
Test Case T1: Print Quality Verification
Objective: To verify that the print quality meets the defined standards.
Procedure: Print a series of test samples and evaluate for clarity and legibility.
Acceptance Criteria: Print must be clear, legible, and free from defects.
Evidence: Documented results of print samples.
Test Case T2: Audit Trail Verification
Objective: To ensure that all printing activities are recorded accurately.
Procedure: Review the audit trail for completeness and accuracy.
Acceptance Criteria: All print jobs must be logged with timestamps and user IDs.
Evidence: Audit trail report.
Deviations
Any deviations from the established acceptance criteria must be documented and reviewed by the Quality Assurance team. Corrective actions should be implemented as necessary.
Approvals
By signing below, the following individuals confirm that they have reviewed and approved this Design Qualification Protocol:
Validation Team Lead: ______________________ Date: __________
Quality Assurance Representative: ______________________ Date: __________
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