Operational Qualification Protocol for Coding Machine Used in Packaging of Nasal & Otic Products
Document Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Coding Machine (Inkjet/Laser) performs as intended for the printing of batch and expiry information on packaging for nasal and otic products, ensuring compliance with URS Annex 11.
Scope
This protocol applies to the Coding Machine used in the packaging area for the production of nasal and otic products, both sterile and non-sterile. It covers the critical parameters associated with print quality and audit trail logs.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Maintenance Team: Responsible for ensuring the equipment is maintained and calibrated as per schedule.
Prerequisites
- Equipment installation and operational checks completed.
- Training of personnel on equipment use and validation procedures.
- Availability of relevant documentation (URS, IQ, etc.).
Equipment Description
The Coding Machine (Inkjet/Laser) is utilized for printing critical information such as batch numbers and expiry dates on packaging materials. It is essential for maintaining product traceability and compliance with regulatory standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Perform print quality checks on sample packaging. | Print quality meets established standards with no smudging or fading. | Print quality audit logs. |
| OQ-002 | Validate audit trail functionality. | Audit trail logs are complete and retrievable. | Audit trail log report. |
Detailed Test Cases
Test Case OQ-001: Print Quality Check
Objective: To ensure the print quality meets established standards.
Procedure: Print a series of test labels and inspect for quality.
Acceptance Criteria: No smudging, fading, or misalignment. All prints must be legible.
Evidence: Documented results of print quality checks, including photographs of prints.
Test Case OQ-002: Audit Trail Validation
Objective: To verify the functionality of the audit trail.
Procedure: Access the audit trail logs and confirm all entries are recorded accurately.
Acceptance Criteria: All logs must be complete and accessible for review.
Evidence: Printout of audit trail logs and confirmation of data integrity checks.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be established if necessary.
Approvals
Approved By: ______________________
Date: ______________________