Document Control
Document Number: DQ-OSD-001
Version: 1.0
Effective Date: YYYY-MM-DD
Review Date: YYYY-MM-DD
Prepared By: [Name]
Approved By: [Name]
Design Qualification Protocol for Sampling Booth in Solid Dosage Form Equipment Validation
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Sampling Booth (Downflow/RLAF) is designed and installed to meet the specified requirements for raw material sampling under containment.
Scope
This protocol applies to the Sampling Booth used in the production/sampling area for solid dosage forms, focusing on critical parameters that impact product quality.
Responsibilities
The Validation Team is responsible for executing this protocol, while the Quality Assurance (QA) team will review and approve the final documentation.
Prerequisites
- Completion of User Requirement Specification (URS)
- Installation Qualification (IQ) Protocol approval
- System design documents available for review
Equipment Description
The Sampling Booth (Downflow/RLAF) is designed for the safe sampling of raw materials while maintaining containment. It features HEPA filtration, adjustable air velocity, and integrated alarm systems for differential pressure (DP) monitoring.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify air velocity at sampling location | Air velocity within specified limits (e.g., 0.5-1.0 m/s) | Measurement logs |
| DQ-02 | HEPA filter integrity test | No leaks detected | Filter test results |
| DQ-03 | Check differential pressure alarms | Alarms activate within specified limits | Alarm test logs |
Detailed Test Cases
Test Case DQ-01: Verify Air Velocity
Measure the air velocity at the sampling location using an anemometer. Ensure that the readings fall within the specified limits of 0.5-1.0 m/s.
Test Case DQ-02: HEPA Filter Integrity Test
Conduct a leak test on the HEPA filter using a suitable method (e.g., aerosol challenge). Document any leaks found and ensure corrective actions are taken.
Test Case DQ-03: Differential Pressure Alarms
Simulate conditions to check that the differential pressure alarms activate at the specified thresholds. Document the activation points and any discrepancies.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the QA team. A root cause analysis should be performed, and corrective actions must be implemented.
Approvals
Prepared by: ____________________ Date: ___________
Reviewed by: ____________________ Date: ___________
Approved by: ____________________ Date: ___________