Document Control
Document ID: PQ-OSD-PC-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Performance Qualification Protocol for Pneumatic Conveying System
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Pneumatic Conveying System operates according to the specified requirements and ensures the safe and effective transfer of materials within the production area.
Scope
This protocol applies to the Pneumatic Conveying System utilized for the conveying of solid dosage forms in the production area, focusing on direct product impact and critical performance parameters.
Responsibilities
The Validation Team is responsible for executing the PQ protocol, while the Quality Assurance (QA) department will oversee the approval process and ensure compliance with regulatory standards.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary equipment and materials.
- Training of personnel involved in the PQ execution.
Equipment Description
The Pneumatic Conveying System operates using an air stream to convey materials from one point to another within the production area. The system is designed to handle solid dosage forms and is critical for maintaining product integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-01 | Measure airflow velocity at pickup and receiver points. | Airflow velocity must meet specifications outlined in URS Annex11. | Calibration records, measurement logs. |
| TP-02 | Verify PLC performance during operation. | PLC must function without errors and meet operational parameters. | PLC logs, operational reports. |
Detailed Test Cases
Test Case TP-01: Airflow Velocity Measurement
1. Set up the airflow measurement device at the pickup point.
2. Activate the Pneumatic Conveying System.
3. Record the airflow velocity readings.
4. Repeat the measurement at the receiver point.
5. Compare readings against URS Annex11 specifications.
Test Case TP-02: PLC Performance Verification
1. Initiate the Pneumatic Conveying System.
2. Monitor PLC for error messages or alerts.
3. Document the operational parameters during the test.
4. Ensure all parameters remain within specified limits.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A CAPA (Corrective and Preventive Action) plan should be developed to address any issues identified during testing.
Approvals
This protocol must be approved by the Quality Assurance department prior to execution. All findings must be reviewed and approved by relevant stakeholders.
Data Integrity Checks
As CSV is required, the following data integrity checks will be performed:
- Validation of data entry procedures to ensure accuracy.
- Audit trails for all electronic data related to the PQ process.
- Regular backups of data collected during the PQ.