Design Qualification (DQ) Protocol for Dispensing Booth
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Dispensing Booth is designed and installed according to specified requirements and is capable of performing its intended function in the API manufacturing process.
Scope
This protocol applies to the Dispensing Booth used for weighing API raw materials in the Production/Dispensing area. It encompasses all activities related to the installation and qualification of the equipment.
Responsibilities
- Validation Team: Responsible for the execution of the DQ protocol and documentation of results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for ensuring the equipment is installed according to specifications.
Prerequisites
- Completion of the Equipment Installation Qualification (IQ).
- Availability of relevant documentation including User Requirements Specification (URS) and design drawings.
- Training of personnel on the operation of the Dispensing Booth.
Equipment Description
The Dispensing Booth is a system designed for the safe weighing of API raw materials. It features HEPA filtration, controlled air velocity, and alarm systems for differential pressure (DP) to ensure a contamination-free environment.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify air velocity at the booth | Must meet specified range as per URS | Calibration report |
| DQ-02 | Check HEPA filter integrity | Must pass integrity test | Test report |
| DQ-03 | Test differential pressure alarms | Must trigger alarms at specified DP | Alarm test log |
Detailed Test Cases
Test Case 1: Air Velocity Verification
Measure the air velocity at multiple points within the Dispensing Booth to ensure compliance with specified ranges outlined in the URS.
Test Case 2: HEPA Filter Integrity Test
Conduct a HEPA filter integrity test using a suitable method (e.g., DOP test) to confirm that the filter is functioning correctly.
Test Case 3: Differential Pressure Alarm Test
Simulate conditions to verify that the differential pressure alarms activate within the defined parameters.
Deviations
Any deviations from the acceptance criteria must be documented, including the nature of the deviation, potential impact, and corrective actions taken.
Approvals
All test results and deviations must be reviewed and approved by the Quality Assurance department before proceeding to the next qualification phase.