Document Control Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Ophthalmic Compounding Vessel
Objective: To validate the operational functionality of the ophthalmic compounding vessel to ensure it meets specified requirements for the preparation of ophthalmic bulk solution and ointment base.
Scope: This protocol applies to the operational qualification of the jacketed stainless steel ophthalmic compounding vessel used in the production area for sterile eye drops and eye ointments.
Responsibilities:
- Validation Team: Conduct the qualification tests and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Personnel: Ensure equipment is operated according to procedures during testing.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on equipment operation.
- Availability of necessary materials and resources for testing.
Equipment Description: The ophthalmic compounding vessel is a jacketed stainless steel vessel designed for the preparation of sterile ophthalmic solutions and ointments. It features temperature control, agitation capabilities, and a PLC audit trail for data integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify agitation functionality at specified RPM. | Agitation must operate within specified RPM range. | Calibration report and operational logs. |
| OQ-02 | Measure temperature hold time during operation. | Temperature must be maintained within specified limits for required duration. | Temperature logs and monitoring records. |
| OQ-03 | Audit PLC for data integrity and accuracy. | PLC audit trail must show no discrepancies. | PLC audit report. |
Detailed Test Cases:
- Test Case OQ-01: Initiate agitation at specified RPM. Monitor and document RPM using calibrated equipment. Verify against acceptance criteria.
- Test Case OQ-02: Set temperature to specified value. Start the timer and monitor temperature for the required hold time. Document temperature readings at defined intervals.
- Test Case OQ-03: Access PLC audit trail. Review logs for completeness and accuracy. Document findings.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. Corrective actions must be implemented as necessary.
Approvals:
- Validation Team Lead: ___________________ Date: ____________
- Quality Assurance Manager: ______________ Date: ____________
Data Integrity Checks:
- Ensure all data recorded during testing is timestamped.
- Verify that all electronic records are backed up and secure.
- Conduct periodic reviews of data logs to ensure consistency and accuracy.