Document Control
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Vial Washing Machine
Objective: To validate the operational performance of the Vial Washing Machine in accordance with the defined acceptance criteria to ensure proper washing of vials before sterilization.
Scope: This protocol applies to the Vial Washing Machine used in the production area for the washing of vials intended for sterile powders and lyophilized products.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for operating the Vial Washing Machine during the qualification process.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of all necessary documentation and equipment.
- Training of personnel on the operation of the Vial Washing Machine.
Equipment Description
The Vial Washing Machine is designed to wash vials prior to sterilization. It operates under controlled conditions to ensure effective cleaning, impacting the quality of the sterile product.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify wash pressure | Pressure within specified range | Pressure log |
| OQ-02 | Verify wash temperature | Temperature within specified range | Temperature log |
| OQ-03 | Verify particulate removal | Particulate count meets standards | Particulate analysis report |
| OQ-04 | Review PLC logs | Logs show no errors | PLC log report |
Detailed Test Cases
Test Case OQ-01: Verify Wash Pressure
Objective: To ensure that the wash pressure of the Vial Washing Machine is within the specified range.
Procedure: Operate the Vial Washing Machine and record the wash pressure during the wash cycle.
Acceptance Criteria: The wash pressure must be within the specified range as defined in the URS Annex11.
Evidence: Documented pressure log must be reviewed and approved.
Test Case OQ-02: Verify Wash Temperature
Objective: To ensure that the wash temperature is maintained within the specified range.
Procedure: Monitor the wash temperature during the wash cycle and record the data.
Acceptance Criteria: The wash temperature must fall within the specified range as defined in the URS Annex11.
Evidence: Documented temperature log must be reviewed and approved.
Test Case OQ-03: Verify Particulate Removal
Objective: To verify that the Vial Washing Machine effectively removes particulates from vials.
Procedure: Conduct particulate analysis on vials after washing.
Acceptance Criteria: The particulate count must meet the established standards.
Evidence: Particulate analysis report must be reviewed and approved.
Test Case OQ-04: Review PLC Logs
Objective: To ensure that the PLC logs show no errors during operation.
Procedure: Review the PLC logs generated during the wash cycle.
Acceptance Criteria: Logs must show no errors.
Evidence: PLC log report must be reviewed and approved.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on the validation process. A corrective action plan must be implemented as necessary.
Approvals
Prepared By: [Insert Name]
Approved By: [Insert Name]
“`