Document Control:
Protocol Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Ophthalmic Ointment Manufacturing Vessel
Objective: To validate the operational performance of the Ophthalmic Ointment Manufacturing Vessel to ensure compliance with the required specifications for the preparation of sterile and non-sterile ointment bases.
Scope: This protocol applies to the operational qualification of the Ophthalmic Ointment Manufacturing Vessel used in the production area for the preparation of sterile/non-sterile ointments.
Responsibilities:
- Validation Team: Prepare and execute the OQ protocol.
- Quality Assurance: Review and approve the OQ protocol and results.
- Production Team: Provide support during testing and ensure equipment availability.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- All required training for personnel must be completed.
- All equipment must be calibrated and maintained according to standard operating procedures.
Equipment Description:
The Ophthalmic Ointment Manufacturing Vessel is designed for the preparation of sterile and non-sterile ointment bases. It features a vacuum mixing capability, temperature control, and torque measurement systems, integrated with PLC for data logging.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify temperature control functionality. | Temperature within specified range (e.g., 20-25°C). | Temperature log records. |
| OQ-02 | Verify vacuum operation. | Vacuum level meets specifications. | Vacuum gauge readings. |
| OQ-03 | Verify mixing speed settings. | Mixing speed within specified range (e.g., 100-500 RPM). | Mixing speed log records. |
| OQ-04 | Verify torque measurement. | Torque within specified range. | Torque measurement records. |
| OQ-05 | Review PLC logs for data integrity. | All logs must be complete and accurate. | PLC log reports. |
Detailed Test Cases:
- Test Case OQ-01: Conduct a temperature check during operation. Record the temperature at five-minute intervals for one hour. Compare with acceptance criteria.
- Test Case OQ-02: Activate the vacuum system and monitor the gauge. Record readings at five-minute intervals until stable. Confirm against specifications.
- Test Case OQ-03: Set the mixing speed to various levels and record the actual speed. Ensure it aligns with the set parameters.
- Test Case OQ-04: Measure torque while mixing at different speeds. Document and compare with established limits.
- Test Case OQ-05: Retrieve PLC logs post-testing. Ensure all entries are present and accurately reflect the operational parameters.
Deviations: Any deviations from the acceptance criteria must be documented, investigated, and resolved prior to final approval of the OQ results.
Approvals:
Prepared By: ______________________ Date: ____________
Approved By: ______________________ Date: ____________