Document ID: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Performance Qualification Protocol for Coding/Printing Machine in IV Infusions
Objective: To validate the performance of the Coding/Printing Machine used for printing batch and expiry information on IV infusion bags and bottles, ensuring compliance with regulatory standards and quality requirements.
Scope: This protocol applies to the Coding/Printing Machine utilized in the packaging area for IV infusions (LVP/SVP – Bags/Bottles). It covers performance qualification activities including print quality verification and audit trail assessments.
Responsibilities:
- Validation Team: Conduct performance qualification testing and documentation.
- Quality Assurance: Review and approve the protocol and results.
- Operations: Ensure proper operation and maintenance of the equipment.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the use of the Coding/Printing Machine.
- Availability of all necessary materials for testing.
Equipment Description:
The Coding/Printing Machine is an inkjet/laser printer designed for printing batch and expiry dates on IV infusion bags and bottles. This equipment is critical for ensuring accurate labeling and compliance with regulatory requirements.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001-01 | Verify print quality on test samples. | Print must be clear, legible, and free of smudges. | Visual inspection report. |
| PQ-001-02 | Check audit trail functionality. | Audit trail must log all print jobs accurately. | Audit trail report. |
Detailed Test Cases:
- Test Case 1: Print Quality Verification
- Procedure: Print a batch of 10 samples and inspect each for clarity and legibility.
- Acceptance Criteria: All samples must be clear and legible.
- Evidence: Documented visual inspection results.
- Test Case 2: Audit Trail Verification
- Procedure: Print a batch and review the audit trail for accuracy.
- Acceptance Criteria: All print jobs must be logged with timestamps and user IDs.
- Evidence: Extracted audit trail report.
Deviations: Any deviations from acceptance criteria must be documented and investigated. A CAPA (Corrective and Preventive Action) plan should be initiated if necessary.
Approvals:
- Prepared By: ______________________
- Reviewed By: ______________________
- Approved By: ______________________
Data Integrity Checks:
- Ensure that all data entries in the audit trail cannot be altered or deleted.
- Implement user access controls to restrict unauthorized changes.
- Conduct regular audits of the audit trail logs to verify accuracy.