Document Control
Document ID: OQ-CTM-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approved By: [Name]
Operational Qualification Protocol for Cap Tightening Machine
Meta Description: This document outlines the Operational Qualification (OQ) protocol for the Cap Tightening Machine used in the production of sterile ophthalmics.
Objective
The objective of this protocol is to validate the Cap Tightening Machine used for capping bottles in the production of sterile ophthalmic products, ensuring compliance with regulatory standards and operational requirements.
Scope
This protocol applies to the Cap Tightening Machine located in the production area of the facility, specifically for the manufacturing of sterile eye drops and eye ointments.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Staff: Responsible for operating the equipment as per the validated procedures.
Prerequisites
- Completion of Installation Qualification (IQ).
- Training of personnel on the operation of the Cap Tightening Machine.
- Availability of necessary tools and materials for testing.
Equipment Description
The Cap Tightening Machine is designed to securely cap bottles containing sterile ophthalmic products. It operates within a specified torque range and is equipped with reject logic and an audit trail feature to ensure compliance with quality standards.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-CTM-01 | Verify torque range settings. | Torque settings within specified limits. | Torque measurement logs. |
| OQ-CTM-02 | Audit trail verification. | Audit trail is complete and accurate. | Audit trail report. |
| OQ-CTM-03 | Reject logic test. | Reject logic activates as expected. | Test results documentation. |
Detailed Test Cases
Test Case 1: Verify Torque Range Settings
Procedure: Use a calibrated torque wrench to measure the torque applied by the machine. Record the readings.
Acceptance Criteria: Torque readings must fall within the specified range as per URS Annex11.
Evidence: Document the readings in the torque measurement logs.
Test Case 2: Audit Trail Verification
Procedure: Access the machine’s audit trail to verify that all operations are logged correctly.
Acceptance Criteria: The audit trail must show timestamps and operator IDs for all actions performed on the machine.
Evidence: Generate and review the audit trail report.
Test Case 3: Reject Logic Test
Procedure: Simulate conditions that should trigger the reject logic and observe the machine’s response.
Acceptance Criteria: The machine must reject any bottles that do not meet the torque specifications.
Evidence: Document the test results and any deviations noted.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be implemented as necessary.
Approvals
Prepared By: [Name] ____________________ Date: __________
Reviewed By: [Name] ____________________ Date: __________
Approved By: [Name] ____________________ Date: __________