Document Control Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Design Qualification Protocol for Raw Material Sampling Booth
Meta Description: This document outlines the Design Qualification Protocol for the Raw Material Sampling Booth used in API manufacturing, focusing on critical parameters and acceptance criteria.
Tags: Design Qualification, Equipment Validation, API Manufacturing, Sampling Booth
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Raw Material Sampling Booth meets the specified requirements for the sampling of API raw materials and intermediates, ensuring product quality and compliance with relevant standards.
Scope
This protocol applies to the Raw Material Sampling Booth located in the Warehouse/Sampling area and covers the validation of its design, installation, and operational performance.
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) for the Raw Material Sampling Booth.
- Installation of the Raw Material Sampling Booth in accordance with engineering specifications.
- Availability of relevant standard operating procedures (SOPs).
Equipment Description
The Raw Material Sampling Booth is designed for the safe and compliant sampling of API raw materials and intermediates. It features HEPA filtration, controlled air velocity, and alarm systems for differential pressure monitoring.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify air velocity at sampling points. | Air velocity within specified range (e.g., 0.45 – 0.75 m/s). | Calibration report and measurement logs. |
| DQ-02 | Conduct HEPA integrity test. | HEPA filter integrity confirmed (no leaks detected). | Test results and certification of HEPA filters. |
| DQ-03 | Check differential pressure alarms functionality. | Alarms trigger at specified DP thresholds. | Alarm test logs and response records. |
Detailed Test Cases
Test Case DQ-01: Air Velocity Verification
Measure the air velocity at multiple sampling points within the booth using a calibrated anemometer. Document the readings and ensure they fall within the acceptance criteria range.
Test Case DQ-02: HEPA Integrity Testing
Perform a HEPA filter integrity test using a suitable aerosol challenge. Document the pass/fail results and maintain records for future reference.
Test Case DQ-03: Differential Pressure Alarm Testing
Simulate conditions to test the differential pressure alarms. Document the response times and functionality of the alarms in accordance with the specifications.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A root cause analysis should be performed, and corrective actions should be implemented as necessary.
Approvals
Prepared By: _______________________ Date: _______________
Reviewed By: _______________________ Date: _______________
Approved By: _______________________ Date: _______________