Document Control
Document Number: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared By: Validation Team
Approved By: Quality Assurance
Performance Qualification Protocol for Mobile Vacuum Transfer System
Meta Description: This document outlines the Performance Qualification (PQ) protocol for the Mobile Vacuum Transfer System used in the production of solid dosage forms, ensuring compliance with URS Annex11 standards.
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Mobile Vacuum Transfer System to ensure it performs as intended for powder transfer between equipment in compliance with regulatory requirements and internal standards.
Scope
This protocol applies to the Mobile Vacuum Transfer System used in the production area for the transfer of solid dosage forms. It encompasses all operational aspects, including installation, operational, and performance qualifications.
Responsibilities
The Validation Team is responsible for executing the PQ protocol, documenting results, and ensuring compliance with all relevant standards. The Quality Assurance department is responsible for reviewing and approving the protocol and results.
Prerequisites
1. Completion of Installation Qualification (IQ) for the Mobile Vacuum Transfer System.
2. Training of personnel on the operation of the system.
3. Availability of necessary materials and equipment for testing.
Equipment Description
The Mobile Vacuum Transfer System is designed for the efficient transfer of powders between equipment within the production area. Key features include suction flow filters, grounding interlocks, and a PLC (Programmable Logic Controller) for operational control.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify suction flow rates | Suction flow rates meet specifications | Flow rate measurement logs |
| PQ-02 | Test filter integrity | No leaks detected | Filter test results |
| PQ-03 | Check grounding interlocks | All interlocks function correctly | Interlock test records |
| PQ-04 | PLC functionality test | PLC operates as intended | PLC operation logs |
Detailed Test Cases
Test Case ID: PQ-01
Test Description: Measure suction flow rates during operation.
Expected Result: Flow rates should be within the defined specifications.
Test Case ID: PQ-02
Test Description: Perform filter integrity tests to confirm no leaks.
Expected Result: All filters should pass integrity tests.
Test Case ID: PQ-03
Test Description: Test grounding interlocks for functionality.
Expected Result: All interlocks should activate/deactivate as specified.
Test Case ID: PQ-04
Test Description: Verify PLC functionality during operation.
Expected Result: PLC should respond correctly to all inputs and outputs.
Deviations
Any deviations from this protocol must be documented and approved by the Quality Assurance department prior to execution of the test.
Approvals
Prepared By: ________________________
Date: ________________________
Approved By: ________________________
Date: ________________________
Data Integrity Checks
1. Ensure all data is recorded in validated systems with appropriate access controls.
2. Conduct periodic audits of data logs and records to confirm completeness and accuracy.
3. Implement checks for data entry errors during test execution.