Document ID: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Nasal/Otic Compounding Vessel
Objective: To validate the operational performance of the Nasal/Otic Compounding Vessel to ensure it meets specified requirements for preparing nasal/otic bulk solutions or suspensions.
Scope: This protocol applies to the Nasal/Otic Compounding Vessel used in the Production area for the preparation of sterile/non-sterile nasal and otic products.
Responsibilities:
- Validation Team: Responsible for executing and documenting the OQ protocol.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Personnel: Responsible for operating the equipment as per the established procedures.
Prerequisites:
- Equipment must be installed and calibrated as per manufacturer’s specifications.
- Operators must be trained on the use of the Nasal/Otic Compounding Vessel.
- Relevant SOPs must be reviewed and approved.
Equipment Description:
The Nasal/Otic Compounding Vessel is a jacketed stainless steel vessel designed for the preparation of nasal and otic bulk solutions or suspensions, ensuring optimal agitation and temperature control.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify agitation speed and consistency. | Agitation speed within specified range. | Calibration records, operator logs. |
| OQ-02 | Measure mixing temperature during operation. | Temperature maintained within specified limits. | Temperature logs, PLC data. |
| OQ-03 | Document mixing time for batch preparation. | Mixing time within defined parameters. | Batch records, operator logs. |
| OQ-04 | Audit PLC data for integrity and accuracy. | Audit trail complete and accurate. | PLC audit report. |
Detailed Test Cases:
- Test ID: OQ-01
- Procedure: Operate the vessel at the specified agitation speed for a defined duration.
- Acceptance Criteria: Agitation speed must be within ±5% of the target speed.
- Evidence: Calibration records and operator logs must be documented.
- Test ID: OQ-02
- Procedure: Measure and record the temperature during mixing.
- Acceptance Criteria: Temperature must remain within ±2°C of the target temperature.
- Evidence: Temperature logs and PLC data must be collected.
- Test ID: OQ-03
- Procedure: Document the total mixing time for a defined batch size.
- Acceptance Criteria: Mixing time must not exceed the established limit.
- Evidence: Batch records and operator logs must be maintained.
- Test ID: OQ-04
- Procedure: Review the PLC audit trail for completeness and accuracy.
- Acceptance Criteria: All entries must be timestamped and user-identified.
- Evidence: PLC audit report must be filed.
Deviations: Any deviations from the acceptance criteria must be documented, and a root cause analysis must be performed.
Approvals:
- Validation Team Lead: ____________________ Date: __________
- Quality Assurance Manager: _______________ Date: __________