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 Machine in Packaging of Nasal & Otic Products
Objective: To validate the installation of the Coding Machine (Inkjet/Laser) used for printing batch and expiry information on Nasal and Otic products, ensuring compliance with URS Annex 11.
Scope: This protocol applies to the installation qualification of the Coding Machine located in the Packaging area for both sterile and non-sterile Nasal & Otic products.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Maintenance Team: Responsible for ensuring the equipment is installed according to specifications.
Prerequisites:
- Completion of the Equipment Purchase Order.
- Installation by qualified personnel.
- Availability of the User Requirements Specification (URS) document.
Equipment Description:
The Coding Machine is designed for printing batch and expiry dates on product packaging using either inkjet or laser technology. This equipment is critical for maintaining product traceability and compliance.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify equipment installation according to manufacturer specifications. | Installation meets all specifications outlined in the URS Annex 11. | Installation checklist signed by qualified personnel. |
| IQ-02 | Check functionality of print quality audit trail logs. | Logs are complete, accurate, and accessible. | Print quality audit log report. |
| IQ-03 | Perform data integrity checks on CSV outputs. | CSV files are complete and match the printed output. | CSV comparison report. |
Detailed Test Cases:
Test Case IQ-01:
- Objective: Verify that the equipment is installed as per the manufacturer’s specifications.
- Steps: Check all installation points and connections.
- Expected Result: All installation points are secure and meet specifications.
Test Case IQ-02:
- Objective: Validate the print quality audit trail logs.
- Steps: Review logs for accuracy and completeness.
- Expected Result: Audit trail logs are complete and without discrepancies.
Test Case IQ-03:
- Objective: Ensure data integrity of the CSV outputs.
- Steps: Compare CSV outputs with printed batch/expiry information.
- Expected Result: CSV outputs match printed information without errors.
Deviations:
Any deviations from the acceptance criteria must be documented and justified in a deviation report, including corrective actions taken.
Approvals:
Prepared By: ______________________
Date: ______________________
Approved By: ______________________
Date: ______________________