Operational Qualification Protocol for Pneumatic Conveying System
Document Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Pneumatic Conveying System operates according to the specified requirements and that it performs effectively within the intended operational parameters.
Scope
This protocol applies to the Pneumatic Conveying System used for the contained transfer of materials in the Solid Dosage Form (OSD) production area.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Operations: Responsible for providing operational support during the qualification process.
Prerequisites
- Completion of Installation Qualification (IQ) for the Pneumatic Conveying System.
- Availability of all necessary equipment and materials for testing.
- Training of personnel on the use of the Pneumatic Conveying System.
Equipment Description
The Pneumatic Conveying System is designed for the contained transfer of solid dosage forms with minimal segregation. It utilizes dense phase conveying technology and operates under controlled pressure conditions.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Verify pressure settings on the DP PLC. | Pressure must be within specified range as per URS Annex11. | Calibration report and PLC logs. |
| OQ-001-02 | Measure flow velocity at the receiver. | Flow velocity must meet defined specifications. | Flow measurement data and charts. |
Detailed Test Cases
Test Case OQ-001-01: Pressure Verification
Procedure: Set the pressure on the DP PLC to the specified operating range. Record the actual pressure readings.
Acceptance Criteria: The pressure must remain within the acceptable range defined in URS Annex11.
Evidence: Document the pressure readings and provide calibration certificates.
Test Case OQ-001-02: Flow Velocity Measurement
Procedure: Use a calibrated flow meter to measure the flow velocity at the receiver during operation.
Acceptance Criteria: The flow velocity must be consistent with the product specifications.
Evidence: Provide flow measurement logs and analysis results.
Deviations
Any deviations from the protocol must be documented and justified. A root cause analysis must be conducted for significant deviations, and corrective actions must be implemented.
Approvals
Prepared by: ___________________ (Validation Team Lead)
Date: ___________________
Reviewed by: ___________________ (Quality Assurance)
Date: ___________________
Approved by: ___________________ (Department Head)
Date: ___________________
Data Integrity Checks
- Ensure that all data recorded during testing is timestamped and attributed to the responsible personnel.
- Implement checks to confirm that all data entries are complete and accurate before finalizing the report.
- Conduct periodic reviews of data logs to ensure compliance with data integrity standards.