Document Control:
Document Number: PQ-OSD-CB-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Continuous Blender in Solid Dosage Form Production
Objective: To validate the performance of the Continuous Blender used in the production of solid dosage forms, ensuring that it meets specified requirements and operates within defined parameters.
Scope: This protocol applies to the Continuous Blender utilized in the production area for continuous blending of solid dosage forms. It encompasses all critical parameters affecting product quality.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Ensures compliance with relevant guidelines and reviews documentation.
- Production Team: Provides operational support and assists in the execution of the protocol.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary equipment and materials for testing.
- Training of personnel on equipment operation and safety procedures.
Equipment Description: The Continuous Blender is designed for the continuous blending of solid dosage forms, allowing for efficient mixing of powders and granules. It operates under controlled feed rates, with real-time data monitoring through PLC controls.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify feed rates at specified RPM. | Feed rates within ±5% of target. | Calibration report and observation log. |
| PQ-02 | Monitor RTD during operation. | RTD readings consistent with expected values. | RTD data logs. |
| PQ-03 | Validate PLC control parameters. | All PLC controls functioning correctly. | PLC control logs and screenshots. |
Detailed Test Cases:
- Test Case PQ-01: Execute blending at specified feed rates and record the actual rates. Compare against the target rates to ensure compliance.
- Test Case PQ-02: Continuously monitor RTD during blending and document any deviations from expected values.
- Test Case PQ-03: Test all PLC control functions, ensuring that all commands are executed as intended and document the results.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed by the validation team and quality assurance. A corrective action plan must be created and implemented.
Approvals:
- Validated By: [Insert Name], [Insert Title]
- Approved By: [Insert Name], [Insert Title]
Data Integrity Checks:
- Ensure all data is logged in real-time and backed up securely.
- Conduct periodic audits of data logs to confirm accuracy.
- Implement user access controls to prevent unauthorized data manipulation.