Document Control
Document 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 Parts Washer in GMP Environment
Objective: To validate the operational performance of the Parts Washer used in the cleaning of equipment parts in the Solid Dosage Form production area.
Scope: This protocol applies to the Parts Washer utilized in the Production/Cleaning area for washing equipment parts that directly impact product quality.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Staff: Responsible for operating the Parts Washer as per the validated procedures.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of Parts Washer and necessary cleaning agents.
- Training of personnel on the operation of the Parts Washer.
Equipment Description:
The Parts Washer is a GMP-compliant equipment designed to wash and clean equipment parts used in the production of solid dosage forms. It operates using a combination of wash temperature, time, pressure, and detergent dosing controlled via a PLC (Programmable Logic Controller).
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify wash temperature settings. | Temperature must be within ±2°C of specified setpoint. | Temperature log. |
| OQ-02 | Verify wash time duration. | Wash time must be within ±5% of specified duration. | Time log. |
| OQ-03 | Verify wash pressure levels. | Pressure must be within ±5 psi of specified setpoint. | Pressure log. |
| OQ-04 | Verify detergent dosing accuracy. | Dosing must be within ±10% of specified amount. | Dosing log. |
| OQ-05 | Verify PLC functionality. | PLC must respond accurately to all commands. | PLC test report. |
Detailed Test Cases:
- Test Case OQ-01: Measure and record the wash temperature during operation. Compare recorded values to setpoint.
- Test Case OQ-02: Start the wash cycle and time the duration. Verify against the expected wash time.
- Test Case OQ-03: Measure the wash pressure during the cycle and compare to the specified pressure range.
- Test Case OQ-04: Check the detergent dosing mechanism to ensure accurate dosing during operation.
- Test Case OQ-05: Simulate various operational commands and verify PLC responses.
Practical Data Integrity Checks:
- Regular backups of temperature, time, pressure, and detergent dosing logs.
- Audit trails for PLC commands and responses.
- Periodic review of logs to ensure data accuracy and completeness.
Deviations: Any deviations from the acceptance criteria must be documented, including the nature of the deviation, investigation, and corrective actions taken.
Approvals:
Prepared By: _______________________ Date: ___________
Approved By: _______________________ Date: ___________