Document Control
Document Title: Design Qualification Protocol for Dispensing Booth
Document Number: DQ-OSD-001
Revision: 1.0
Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Downflow Dispensing Booth
Meta Description: This document outlines the Design Qualification Protocol for the Downflow Dispensing Booth used in Solid Dosage Form production, focusing on critical parameters and compliance standards.
Objective
The objective of this Design Qualification (DQ) Protocol is to verify that the Downflow Dispensing Booth meets the specified requirements for weighing and dispensing operations under containment conditions.
Scope
This protocol applies to the Downflow Dispensing Booth utilized in the production area for solid dosage forms. It encompasses the evaluation of critical parameters impacting product quality and safety.
Responsibilities
The Validation Team is responsible for executing the DQ protocol, documenting results, and ensuring compliance with established standards. The Quality Assurance Team will review and approve the protocol and results.
Prerequisites
All personnel involved must be trained in equipment operation and validation principles. The equipment must be installed and operational prior to protocol execution.
Equipment Description
The Downflow Dispensing Booth is designed for weighing and dispensing solid dosage forms under controlled conditions to prevent contamination. Key features include HEPA filtration, air velocity control, and alarm systems for differential pressure monitoring.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Measure air velocity at various points within the booth. | Air velocity must be within the specified range as per URS. | Calibration report and measurement logs. |
| DQ-02 | Verify HEPA filter integrity using appropriate testing methods. | HEPA filter integrity must pass as per ISO 14644 guidelines. | Integrity test results. |
| DQ-03 | Check the functionality of differential pressure alarms. | Alarms must activate within specified limits. | Alarm test logs. |
Detailed Test Cases
Test Case DQ-01
Objective: To measure air velocity within the booth.
Method: Utilize an anemometer to assess air velocity at designated points.
Expected Result: Air velocity should be within the range of [insert range].
Test Case DQ-02
Objective: To verify HEPA filter integrity.
Method: Conduct a DOP test or equivalent.
Expected Result: No leakage detected, integrity maintained.
Test Case DQ-03
Objective: To ensure differential pressure alarms function correctly.
Method: Simulate conditions to test alarm activation.
Expected Result: Alarms activate as per defined parameters.
Deviations
Any deviations from the acceptance criteria must be documented and evaluated for impact on product quality and compliance. Corrective actions must be implemented where necessary.
Approvals
The protocol and results must be reviewed and approved by the Quality Assurance Team prior to finalization.