Operational Qualification Protocol for Coding Machine Used in Prefilled Syringes & Cartridges
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Coding Machine (Laser / Inkjet) used for printing batch and expiry information on prefilled syringes and cartridges operates according to predefined specifications and meets the requirements outlined in the User Requirement Specification (URS) Annex 11.
Scope
This protocol applies to the Coding Machine utilized in the packaging area for the printing of batch and expiry information on prefilled syringes and cartridges. It covers the validation of equipment performance, ensuring compliance with quality standards and regulatory requirements.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Engineering: Responsible for providing technical support and equipment maintenance.
Prerequisites
- Completion of Installation Qualification (IQ).
- Availability of required materials and equipment.
- Training of personnel on the operation of the Coding Machine.
Equipment Description
The Coding Machine (Laser / Inkjet) is designed to print batch and expiry dates on prefilled syringes and cartridges. It operates using advanced printing technology to ensure high-quality print output and compliance with regulatory standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Verify print quality audit trail logs. | All logs are complete and accurate, meeting URS Annex 11 requirements. | Audit trail log report. |
| OQ-001-02 | Check for proper ink adhesion and clarity. | Prints are clear and durable, with no smudging or fading. | Sample prints for review. |
| OQ-001-03 | Confirm system calibration. | Calibration meets manufacturer specifications. | Calibration certificate. |
Detailed Test Cases
Test Case OQ-001-01
Verify that the coding machine generates complete audit trail logs for each print job. Check that logs include date, time, operator ID, and any error messages.
Test Case OQ-001-02
Perform a visual inspection of printed syringes and cartridges to ensure that the batch and expiry dates are legible and adhere to the surface without smudging.
Test Case OQ-001-03
Calibrate the coding machine according to the manufacturer’s instructions and verify that the calibration results align with specified tolerances.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be conducted, and corrective actions must be implemented.
Approvals
All results must be reviewed and approved by the Quality Assurance team before the Coding Machine is deemed operationally qualified.
Data Integrity Checks
Practical data integrity checks include:
- Verification of user access controls to ensure only authorized personnel can modify settings.
- Regular audits of audit trail logs to ensure no alterations have been made post-printing.
- Backup of critical data to ensure recovery in case of system failure.