Document Control
Document ID: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Temperature Controlled Warehouse
Objective: To validate the performance of the temperature-controlled warehouse used for the storage of raw materials, ensuring compliance with regulatory requirements and product integrity.
Scope: This protocol applies to the performance qualification of the temperature-controlled warehouse specifically designed for raw material storage within the pharmaceutical manufacturing facility.
Responsibilities:
- Validation Team: Responsible for executing the protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Warehouse Management: Responsible for ensuring that the warehouse is maintained in accordance with the established specifications.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all required equipment and materials.
- Training of personnel involved in the performance qualification process.
Equipment Description:
The temperature-controlled warehouse is designed to maintain specific temperature and relative humidity (RH) conditions for the storage of raw materials. It features advanced monitoring systems for temperature and RH, equipped with alarms and audit trails to ensure compliance with regulatory requirements.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Perform temperature mapping of the warehouse. | Temperature remains within specified limits as per URS Annex 11. | Mapping report and temperature logs. |
| PQ-02 | Perform RH mapping of the warehouse. | RH remains within specified limits as per URS Annex 11. | Mapping report and RH logs. |
| PQ-03 | Test alarm functionality. | Alarms trigger within specified limits. | Alarm test log. |
| PQ-04 | Review audit trail functionality. | Audit trail captures all critical parameters accurately. | Audit trail report. |
Detailed Test Cases:
Test Case ID: PQ-01
- Objective: Validate temperature uniformity within the warehouse.
- Method: Install temperature sensors at various locations and record temperatures over a 24-hour period.
- Expected Result: All recorded temperatures should remain within specified limits.
Test Case ID: PQ-02
- Objective: Validate RH uniformity within the warehouse.
- Method: Install RH sensors at various locations and record RH levels over a 24-hour period.
- Expected Result: All recorded RH levels should remain within specified limits.
Test Case ID: PQ-03
- Objective: Ensure alarm systems function correctly.
- Method: Simulate temperature and RH excursions and verify alarm activation.
- Expected Result: Alarms activate as specified in the SOP.
Test Case ID: PQ-04
- Objective: Verify audit trail functionality.
- Method: Review audit trail logs for accuracy and completeness.
- Expected Result: All critical parameter changes are logged accurately.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality and regulatory compliance.
Approvals:
- Validation Team Lead: ______________________ Date: ___________
- Quality Assurance Manager: ______________________ Date: ___________
- Warehouse Manager: ______________________ Date: ___________