Document Control
Document Number: DQ-SS-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Design Qualification Protocol for Solvent Storage Tank in API Manufacturing
Meta Description: This Design Qualification Protocol outlines the validation process for the Solvent Storage Tank used in API manufacturing, ensuring compliance with critical parameters and acceptance criteria.
Tags: Equipment Validation, API Manufacturing, Solvent Storage Tank, Design Qualification
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Solvent Storage Tank (SS / GL) used in API manufacturing meets the specified requirements and is suitable for its intended use in storing solvents.
Scope
This protocol applies to the Solvent Storage Tank located in the Production area, focusing on its role in the storage of solvents used in chemical synthesis and purification processes.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for providing technical support and equipment specifications.
Prerequisites
- Completion of User Requirements Specification (URS).
- Availability of equipment specifications and installation documentation.
- Training of personnel involved in the validation process.
Equipment Description
The Solvent Storage Tank (SS / GL) is designed to store solvents used in the API manufacturing process. The tank is equipped with level, temperature, and pressure monitoring systems, and is integrated with a PLC for data logging and audit trail purposes.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-01 | Verify tank integrity and installation. | No leaks; proper installation. | Inspection report. |
| DQ-02 | Check level, temperature, and pressure sensors. | All sensors operational within specifications. | Calibration certificates. |
| DQ-03 | Review PLC audit trail functionality. | Complete and accurate logs. | Audit trail report. |
Detailed Test Cases
Test Case DQ-01
Objective: Verify tank integrity and installation.
Procedure: Conduct a visual inspection of the tank for any signs of leaks or improper installation. Review installation documentation for compliance with specifications.
Acceptance Criteria: No leaks observed; installation meets specifications.
Evidence: Inspection report documenting findings.
Test Case DQ-02
Objective: Check level, temperature, and pressure sensors.
Procedure: Perform functional testing of each sensor to ensure they are operational and calibrated correctly.
Acceptance Criteria: All sensors must operate within specified ranges.
Evidence: Calibration certificates and functional test results.
Test Case DQ-03
Objective: Review PLC audit trail functionality.
Procedure: Access the PLC system and review the audit trail logs for completeness and accuracy.
Acceptance Criteria: The audit trail must show complete logging of all activities.
Evidence: Generated audit trail report.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be conducted, and corrective actions must be implemented.
Approvals
Prepared By: ______________________ Date: ___________
Reviewed By: ______________________ Date: ___________
Approved By: ______________________ Date: ___________