Document Control:
Document Number: DQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Prepared by: [Name]
Approved by: [Name]
Design Qualification Protocol for Ambient Warehouse
Objective: To establish and validate the design specifications of the Ambient Warehouse to ensure compliance with regulatory standards and maintain the integrity of stored materials.
Scope: This protocol applies to the Ambient Warehouse utilized for the storage of general materials, focusing on temperature and relative humidity (RH) mapping. The impact on products is indirect, and the criticality is classified as major.
Responsibilities:
- Validation Team: Oversee execution and documentation of the DQ protocol.
- Quality Assurance: Review and approve the DQ protocol and results.
- Facility Management: Ensure the Ambient Warehouse is maintained and operational during validation activities.
Prerequisites:
- Completion of User Requirements Specification (URS) as per Annex 15.
- Installation of temperature and RH monitoring equipment.
- Training of personnel involved in the validation process.
Equipment Description:
The Ambient Warehouse is designed for the storage of general materials under controlled environmental conditions. It is equipped with temperature and humidity monitoring systems to ensure compliance with established parameters.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Temperature Mapping | Temperature must remain within specified limits as per URS Annex 15. | Temperature mapping report. |
| T2 | RH Mapping | Relative humidity must remain within specified limits as per URS Annex 15. | RH mapping report. |
Detailed Test Cases:
- Test Case T1: Conduct temperature mapping using calibrated sensors placed at various locations within the warehouse. Document temperatures at regular intervals over a defined period.
- Test Case T2: Conduct RH mapping similarly, ensuring sensors are placed strategically to capture variations in humidity levels throughout the warehouse.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be implemented as necessary, and re-testing should be conducted to ensure compliance.
Approvals:
Prepared by: ____________________ Date: ___________
Approved by: ____________________ Date: ___________