Design Qualification Protocol for Pneumatic Conveying System in Solid Dosage Form
Document Number: DQ-OSD-PC-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Pneumatic Conveying System for Solid Dosage Form meets the specified requirements and functions as intended in the production and material transfer area.
Scope
This protocol applies to the Pneumatic Conveying System used for conveying solid dosage forms via an air stream, impacting the product directly. It covers the validation process from installation to operational qualification.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for ensuring the system is installed as per specifications.
Prerequisites
- Completion of Installation Qualification (IQ).
- Availability of User Requirements Specification (URS) Annex 11.
- Training of personnel on system operation and validation procedures.
Equipment Description
The Pneumatic Conveying System is designed to convey solid dosage forms using an air stream. The system includes a pickup and receiver performance PLC to monitor and control airflow velocity, ensuring efficient material transfer.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify airflow velocity at pickup point. | Airflow velocity meets specifications as per URS Annex 11. | Measurement logs. |
| DQ-02 | Verify receiver performance. | Receiver performs within defined limits. | Performance reports. |
| DQ-03 | Check PLC functionality. | PLC operates without errors during test. | PLC logs. |
Detailed Test Cases
Test Case DQ-01: Airflow Velocity Verification
Measure the airflow velocity at the pickup point using calibrated equipment. The velocity should be within the specified range outlined in the URS Annex 11.
Test Case DQ-02: Receiver Performance Verification
Conduct performance tests on the receiver to ensure it operates within the defined limits for solid dosage forms.
Test Case DQ-03: PLC Functionality Check
Run the PLC through a series of operational tests to confirm it functions correctly without errors or interruptions.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A corrective action plan should be developed and approved by the Quality Assurance team.
Approvals
Prepared By: ______________________ Date: ___________
Approved By: ______________________ Date: ___________