Document Control
Document Number: OQ-DB-001
Version: 1.0
Date: 2023-10-01
Prepared By: [Your Name]
Reviewed By: [Reviewer Name]
Approved By: [Approver Name]
Operational Qualification Protocol for Dispensing Booth
Meta Description: This document outlines the Operational Qualification (OQ) protocol for the Dispensing Booth used in API manufacturing, detailing critical parameters and acceptance criteria.
Objective
The objective of this protocol is to ensure that the Dispensing Booth operates within specified parameters to maintain the integrity of API raw materials during weighing, in compliance with regulatory standards.
Scope
This protocol applies to the Dispensing Booth used in the Production/Dispensing area for weighing API raw materials. It covers validation of critical parameters affecting product quality.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with acceptance criteria. Quality Assurance will review and approve the final report.
Prerequisites
All personnel involved in the qualification process must be trained in Good Manufacturing Practices (GMP) and familiar with the operation of the Dispensing Booth.
Equipment Description
The Dispensing Booth is a controlled environment system designed for the accurate weighing of API raw materials. It features HEPA filtration, air velocity control, and alarms for differential pressure monitoring.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-DB-01 | Measure air velocity at various points inside the booth. | Air velocity must be within 0.45 to 0.75 m/s. | Velocity measurement logs. |
| OQ-DB-02 | Perform HEPA filter integrity test. | HEPA filter must maintain integrity with no leaks. | Integrity test report. |
| OQ-DB-03 | Verify differential pressure alarms functionality. | DP alarms must activate at specified thresholds. | Alarm test logs. |
Detailed Test Cases
Test ID: OQ-DB-01
Procedure: Use an anemometer to measure air velocity at designated points in the booth.
Acceptance Criteria: Air velocity readings must fall within the range of 0.45 to 0.75 m/s.
Test ID: OQ-DB-02
Procedure: Conduct a HEPA filter integrity test using a suitable method (e.g., DOP test).
Acceptance Criteria: No leaks should be detected, confirming filter integrity.
Test ID: OQ-DB-03
Procedure: Simulate conditions to test the activation of differential pressure alarms.
Acceptance Criteria: Alarms must activate at the specified differential pressure thresholds.
Deviations
Any deviations from the specified acceptance criteria must be documented and justified in the final report. Corrective actions must be implemented as necessary.
Approvals
All test results and final reports must be reviewed and approved by the Quality Assurance department before the Dispensing Booth can be deemed operationally qualified.