Operational Qualification Protocol for Capping Machine Used in IV Infusions
Document Number: OQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Prepared By: [Name]
Reviewed By: [Name]
Approved By: [Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Capping Machine performs according to its intended use and meets the specified acceptance criteria outlined in the User Requirement Specification (URS) Annex 11.
Scope
This protocol applies to the Capping Machine used in the production area for capping IV infusion bottles and bags. It encompasses the evaluation of critical parameters and data integrity checks.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with regulatory requirements. The Quality Assurance (QA) department will review and approve the final report.
Prerequisites
All personnel involved in this OQ must be trained on the operation of the Capping Machine and the associated validation processes. Equipment must be installed and calibrated according to the manufacturer’s specifications.
Equipment Description
The Capping Machine (ROPP/Screw) is designed to securely cap IV infusion bottles and bags. It is equipped with torque control mechanisms to ensure proper sealing. The machine’s critical parameters include torque range, reject logic, and audit trail capabilities.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify torque range settings | Torque settings within specified limits | Calibration certificate |
| OQ-002 | Test reject logic functionality | Reject logic activates as per design | Test log |
| OQ-003 | Audit trail review | Complete and accurate audit trail | Audit trail report |
Detailed Test Cases
Test Case OQ-001: Verify Torque Range Settings
Objective: To ensure the capping machine’s torque settings are within specified limits.
Procedure: Measure the torque applied during capping using a calibrated torque meter. Compare results against the specified range.
Acceptance Criteria: Torque settings must fall within the limits defined in the URS Annex 11.
Evidence: Documented measurement results and calibration certificates.
Test Case OQ-002: Test Reject Logic Functionality
Objective: To verify that the reject logic functions correctly to prevent defective caps.
Procedure: Simulate a defective cap scenario and observe if the reject logic activates.
Acceptance Criteria: The machine must reject the defective cap as per design specifications.
Evidence: Test log documenting the scenario and machine response.
Test Case OQ-003: Audit Trail Review
Objective: To confirm that the audit trail captures all relevant operations.
Procedure: Review the audit trail generated by the machine for completeness and accuracy.
Acceptance Criteria: The audit trail must include timestamps and operator IDs for all actions.
Evidence: Audit trail report extracted from the machine’s database.
Deviations
Any deviations from the acceptance criteria must be documented and addressed according to the deviation management procedure.
Approvals
Prepared By: ____________________ Date: ___________
Reviewed By: ____________________ Date: ___________
Approved By: ____________________ Date: ___________