Document Control:
Document ID: PQ-AW-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Ambient Warehouse Equipment
Objective: To validate the performance of the Ambient Warehouse used for the storage of general materials, ensuring compliance with regulatory requirements and internal standards.
Scope: This protocol applies to the Ambient Warehouse facility designated for the storage of raw materials and is applicable to all operations involving this equipment.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Warehouse Manager: Responsible for ensuring the warehouse conditions are maintained during the qualification process.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary equipment and materials for testing.
- Personnel trained in validation procedures and data integrity practices.
Equipment Description:
The Ambient Warehouse is a facility designed for the storage of general materials. It operates under controlled temperature and relative humidity conditions to ensure the integrity of stored materials.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-T1 | Perform temperature and RH mapping throughout the warehouse. | Temperature: 15-25°C; RH: 30-60% as per URS Annex15. | Mapping report with graphical representation. |
Detailed Test Cases:
- Test Case 1: Conduct temperature mapping at various locations within the warehouse. Record temperatures at specified intervals.
- Test Case 2: Conduct RH mapping at various locations within the warehouse. Record relative humidity at specified intervals.
- Test Case 3: Analyze mapping data to confirm compliance with acceptance criteria.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A formal deviation report should be created for any significant discrepancies encountered during testing.
Approvals:
- Validation Team Lead: ____________________ Date: _______________
- Quality Assurance Manager: ____________________ Date: _______________
- Warehouse Manager: ____________________ Date: _______________