Design Qualification Protocol for Pneumatic Conveying System in Solid Dosage Form Production
Document Number: DQ-OSD-PC-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective: To validate the Pneumatic Conveying System for contained transfer of solid dosage forms, ensuring compliance with defined specifications and regulatory requirements.
Scope: This protocol covers the Design Qualification of the Pneumatic Conveying System used for material transfer in the production area, focusing on critical parameters and acceptance criteria as per URS Annex11.
Responsibilities:
- Validation Team: Overall execution and documentation of the DQ protocol.
- Quality Assurance: Review and approval of the DQ protocol and results.
- Engineering: Provide technical support and equipment specifications.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) must be completed prior to DQ.
- Availability of all necessary documentation and equipment manuals.
Equipment Description: The Pneumatic Conveying System is designed for the dense phase transfer of solid dosage forms, ensuring minimal segregation and contamination during the transfer process. The system operates under controlled pressure and flow velocity parameters monitored by a DP PLC.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify pressure settings on the PLC | Pressure must be within specified limits | Calibration report |
| DQ-02 | Measure flow velocity | Flow velocity must meet operational standards | Flow measurement logs |
| DQ-03 | Check receiver functionality | Receiver must operate without leaks | Leak test report |
Detailed Test Cases:
- Test Case 1: Confirm that the pressure settings on the PLC align with the specified operational limits. Document any discrepancies.
- Test Case 2: Measure the flow velocity during operation and ensure it meets the defined criteria. Record all findings.
- Test Case 3: Conduct a leak test on the receiver to confirm its integrity. Provide evidence of any leaks found.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis will be performed, and corrective actions will be implemented as necessary.
Approvals:
- ____________________ (Validation Team Lead)
- ____________________ (Quality Assurance)
- ____________________ (Engineering)
Data Integrity Checks:
- Ensure all data recorded during testing is timestamped and signed by the responsible personnel.
- Implement a backup system for data storage to prevent loss of information.
- Conduct periodic reviews of data logs to ensure compliance with validation requirements.