Document Control Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Coding Machine in Packaging
Objective: The objective of this Operational Qualification (OQ) protocol is to validate the performance of the coding machine used for printing batch and expiry details on suppositories and implants.
Scope: This protocol applies to the coding machine (Inkjet / Laser) used in the packaging area for direct product impact. It encompasses the validation of print quality audit trail logs as per URS Annex11.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Equipment Owner: Responsible for ensuring equipment availability and maintenance.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on the operation of the coding machine.
- Availability of necessary materials and tools for testing.
Equipment Description:
The coding machine is designed to print batch and expiry details on suppositories and implants using either inkjet or laser technology. It is critical for ensuring traceability and compliance with regulatory requirements.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify print quality of batch/expiry details. | Print quality must meet specifications outlined in URS Annex11. | Print quality audit trail logs. |
| OQ-02 | Check functionality of audit trail logs. | Audit trail logs must be complete and accessible. | Audit trail log printout. |
Detailed Test Cases:
Test Case OQ-01: Verify Print Quality
Objective: To ensure that the print quality of batch and expiry details meets the required standards.
Procedure: Print a sample batch and expiry label. Inspect for clarity, legibility, and completeness.
Acceptance Criteria: The printed label must be clear, legible, and contain all required information as per URS Annex11.
Evidence: Print quality audit trail logs must be documented and reviewed.
Test Case OQ-02: Check Audit Trail Logs
Objective: To verify that the audit trail logs are functioning correctly and are complete.
Procedure: Access the audit trail logs from the coding machine. Ensure that all entries are logged correctly.
Acceptance Criteria: The logs must show a complete history of print operations without any gaps.
Evidence: A printout of the audit trail logs must be included in the final report.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be taken as necessary, and a report should be generated for Quality Assurance review.
Approvals:
Approved By: [Insert Name] – [Insert Title]
Date: [Insert Date]
“`