Operational Qualification Protocol for Solution Preparation Tank
Document Control:
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective:
The purpose of this Operational Qualification (OQ) protocol is to verify that the Solution Preparation Tank operates according to specified requirements and meets the acceptance criteria outlined in the User Requirement Specification (URS) Annex 11.
Scope:
This protocol applies to the Solution Preparation Tank used in the production of both sterile and non-sterile nasal and otic products within the production area.
Responsibilities:
- Validation Team: Overall execution and documentation of the OQ protocol.
- Production Team: Ensure equipment is ready for validation and assist in testing.
- Quality Assurance: Review and approve the OQ protocol and results.
Prerequisites:
- Equipment installation and operational qualification completed.
- All personnel trained on equipment operation and safety procedures.
- Availability of necessary materials and resources for testing.
Equipment Description:
The Solution Preparation Tank is designed to dissolve ingredients and prepare formulations for nasal and otic products. It features temperature control, mixing capabilities, and is equipped with PLC logging for data integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-T1 | Verify temperature settings during operation. | Temperature within ±2°C of set point. | Temperature log report. |
| OQ-001-T2 | Check mixing speed during formulation. | Mixing speed within specified range. | Mixing speed log report. |
| OQ-001-T3 | Conduct conductivity measurement. | Conductivity within defined limits. | Conductivity measurement report. |
| OQ-001-T4 | Review PLC logs for data integrity. | All logs should be complete and without discrepancies. | PLC log review report. |
Detailed Test Cases:
- Test Case OQ-001-T1:
Procedure: Set the temperature to the specified set point and monitor for 30 minutes. Record the temperature at 5-minute intervals.
Acceptance Criteria: Temperature must remain within ±2°C of the set point.
- Test Case OQ-001-T2:
Procedure: Set the mixing speed and run the tank for 15 minutes. Record the mixing speed every 5 minutes.
Acceptance Criteria: Mixing speed must remain within the specified range.
- Test Case OQ-001-T3:
Procedure: Measure the conductivity of the solution using calibrated equipment.
Acceptance Criteria: Conductivity must be within defined limits.
- Test Case OQ-001-T4:
Procedure: Review PLC logs for completeness and accuracy.
Acceptance Criteria: All logs must be complete and show no discrepancies.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan must be developed and implemented as necessary.
Approvals:
Prepared By: _______________________ Date: __________
Reviewed By: _______________________ Date: __________
Approved By: _______________________ Date: __________