Document Control:
Document Number: IQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Installation Qualification Protocol for Coding/Printing Machine in IV Infusions
Objective: To establish and document the Installation Qualification (IQ) for the Coding/Printing Machine used for printing batch and expiry information on IV infusion bags and bottles.
Scope: This protocol applies to the Coding/Printing Machine (Inkjet/Laser) utilized in the Packaging/Primary area for IV infusion products. It covers the verification of installation and functionality of the equipment to ensure compliance with regulatory requirements.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
- Equipment Owner: Responsible for ensuring equipment is available and operational for testing.
Prerequisites:
- Equipment must be installed as per manufacturer’s specifications.
- All necessary utilities (power, air, etc.) must be available and functional.
- Personnel must be trained on equipment operation and safety procedures.
Equipment Description:
The Coding/Printing Machine (Inkjet/Laser) is designed for printing batch and expiry information directly on IV infusion bags and bottles. It is critical for ensuring product traceability and compliance with regulatory standards. The machine is capable of maintaining high print quality and includes features for audit trail verification.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation as per manufacturer’s specifications. | Installation meets all specified requirements. | Installation checklist signed by validation team. |
| IQ-02 | Check functionality of the coding/printing machine. | Machine operates without errors and produces clear print. | Print samples and machine operation logs. |
| IQ-03 | Perform print quality verification audit trail. | Audit trail is complete and accessible. | Audit trail report and verification logs. |
Detailed Test Cases:
- Test ID: IQ-01
- Procedure: Verify that the equipment is installed according to the manufacturer’s specifications.
- Acceptance Criteria: All installation requirements must be met.
- Evidence: Documented installation checklist.
- Test ID: IQ-02
- Procedure: Operate the machine and verify that it functions correctly.
- Acceptance Criteria: Machine must operate without any errors.
- Evidence: Record of machine operation and print quality samples.
- Test ID: IQ-03
- Procedure: Review the audit trail for print quality verification.
- Acceptance Criteria: Audit trail must be complete and readily accessible.
- Evidence: Audit trail report.
Deviations: Any deviations from the acceptance criteria must be documented and addressed in accordance with the deviation management process.
Approvals:
- Validation Team Lead: ____________________ Date: ___________
- Quality Assurance: ____________________ Date: ___________
Data Integrity Checks:
- Verify that all prints are logged with timestamps and operator IDs.
- Ensure that any errors during printing are recorded in the machine’s log.
- Confirm that the audit trail is immutable and protected from unauthorized access.