Document Control Number: PQ-OSD-PC-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Pneumatic Conveying System
Objective
The objective of this Performance Qualification (PQ) Protocol is to validate the Pneumatic Conveying System to ensure that it operates consistently and reliably within predetermined specifications, thus guaranteeing the quality of the solid dosage form produced.
Scope
This protocol applies to the Pneumatic Conveying System used in the production and material transfer of solid dosage forms. It covers the operational parameters critical to product quality and compliance with regulatory standards.
Responsibilities
The following personnel are responsible for the execution and oversight of this PQ protocol:
- Validation Team: Responsible for the execution of the protocol and documentation of results.
- Quality Assurance: Responsible for review and approval of the protocol and results.
- Production Team: Responsible for providing necessary access and support during testing.
Prerequisites
- Completion of Installation Qualification (IQ) for the Pneumatic Conveying System.
- Successful completion of Operational Qualification (OQ) testing.
- Availability of all necessary equipment and materials for testing.
Equipment Description
The Pneumatic Conveying System is designed for contained transfer of solid dosage forms with minimal segregation. The system operates using dense phase conveying technology, ensuring efficient and safe material transfer.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-01 | Measure pressure during operation. | Pressure within specified range. | Pressure log. |
| TP-02 | Verify flow velocity at receiver. | Flow velocity meets design specifications. | Flow velocity report. |
| TP-03 | Check DP PLC functionality. | PLC operates without errors. | PLC test results. |
Detailed Test Cases
Test Case 1: Pressure Measurement
Objective: To verify that the pressure during operation remains within the specified range.
Procedure: Monitor pressure readings during the operation of the Pneumatic Conveying System for a defined duration.
Acceptance Criteria: Pressure readings must remain within the range of [insert range].
Evidence: Documented pressure log with timestamps.
Test Case 2: Flow Velocity Verification
Objective: To ensure the flow velocity at the receiver meets design specifications.
Procedure: Measure the flow velocity at the receiver using calibrated equipment.
Acceptance Criteria: Flow velocity must be within [insert specifications].
Evidence: Flow velocity report with calibration details.
Test Case 3: DP PLC Functionality Check
Objective: To confirm that the DP PLC operates without errors during the conveying process.
Procedure: Run the PLC diagnostics and monitor for any error codes during operation.
Acceptance Criteria: No error codes should be reported.
Evidence: PLC test results documentation.
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
Prepared by: ______________________
Date: ______________________
Approved by: ______________________
Date: ______________________
Data Integrity Checks
As CSV is required, the following data integrity checks will be implemented:
- Ensure all data entries are timestamped and logged.
- Regular audits of data logs to ensure accuracy and completeness.
- Implement access controls to prevent unauthorized data modifications.