Document Number: OQ-VD-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Vacuum Degassing System
Objective: To validate the operational performance of the Vacuum Degassing System used in the production of suppositories and implants, ensuring that it effectively removes air bubbles in compliance with URS Annex11.
Scope: This protocol applies to the Vacuum Degassing System located in the Production area, specifically for the preparation of suppositories and implants.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Personnel: Operate the equipment as per the validated procedures.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on equipment operation.
- Availability of necessary materials and equipment for testing.
Equipment Description:
The Vacuum Degassing System is designed to effectively remove air bubbles from the product formulation. It operates under controlled vacuum pressure and is equipped with an audit trail logging system to ensure compliance and traceability.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify vacuum pressure settings | Vacuum pressure must be within specified range | Calibration logs, Pressure readings |
| OQ-002 | Measure degassing time | Degassing time must meet specified duration | Time logs, Audit trail |
| OQ-003 | Review audit trail logs | All logs must be complete and accurate | Audit trail report |
Detailed Test Cases:
- Test ID: OQ-001
- Procedure: Set the vacuum pressure to the specified value and verify using calibrated gauge.
- Acceptance Criteria: The vacuum pressure must be within the specified range.
- Evidence: Calibration logs and pressure readings must be documented.
- Test ID: OQ-002
- Procedure: Start the degassing cycle and measure the time taken to complete.
- Acceptance Criteria: Degassing time must not exceed the specified duration.
- Evidence: Time logs and audit trail must be reviewed.
- Test ID: OQ-003
- Procedure: Review the audit trail logs for completeness and accuracy.
- Acceptance Criteria: All logs must be complete and accurate.
- Evidence: Audit trail report must be documented.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions should be initiated as necessary.
Approvals:
- Validation Manager: ___________________ Date: ____________
- Quality Assurance: ___________________ Date: ____________
Data Integrity Checks: Ensure that all data recorded during the test is accurate, complete, and securely stored to maintain integrity. This includes verifying that the audit trail logs are tamper-proof and that all personnel involved in the testing are trained and authorized to perform their tasks.