Document Control
Document ID: OQ-DB-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Operational Qualification Protocol for Dispensing Booth in Solid Dosage Form Production
Meta Description: This document outlines the Operational Qualification (OQ) protocol for the Dispensing Booth used in Solid Dosage Form production, focusing on critical parameters and compliance with ISO standards.
Tags: Equipment Validation, OQ, Dispensing Booth, Solid Dosage Form
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Dispensing Booth operates within specified limits and meets the requirements outlined in the User Requirement Specification (URS) and ISO 14644 Annex 15.
Scope
This protocol applies to the Dispensing Booth used in the Production/Dispensing area for weighing and dispensing under containment in Solid Dosage Form (OSD) manufacturing.
Responsibilities
The Validation Team is responsible for executing the OQ protocol, documenting results, and reporting any deviations. The Quality Assurance (QA) team is responsible for reviewing and approving the protocol and results.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- Personnel must be trained on the operation of the Dispensing Booth.
- All necessary tools and materials must be available for testing.
Equipment Description
The Dispensing Booth (Downflow) is designed for weighing and dispensing materials under controlled conditions to prevent contamination. It features HEPA filtration, adjustable air velocity, and alarms for differential pressure (DP).
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-DB-01 | Measure air velocity at specified points within the booth. | Air velocity must be within 0.45 to 0.75 m/s. | Velocity measurement logs. |
| OQ-DB-02 | Perform HEPA integrity test. | HEPA filters must maintain integrity with no leaks. | Integrity test reports. |
| OQ-DB-03 | Check differential pressure alarms functionality. | DP alarms must trigger at specified thresholds. | Alarm test logs. |
Detailed Test Cases
Test Case OQ-DB-01: Air Velocity Measurement
Objective: To ensure the air velocity within the booth meets specifications.
Procedure: Use an anemometer to measure air velocity at designated points within the booth. Record measurements.
Acceptance Criteria: Air velocity must be within 0.45 to 0.75 m/s.
Evidence: Documented velocity measurement logs.
Test Case OQ-DB-02: HEPA Integrity Test
Objective: To confirm the integrity of HEPA filters.
Procedure: Conduct a HEPA filter integrity test using a suitable method (e.g., DOP test).
Acceptance Criteria: No leaks detected in the HEPA filter.
Evidence: Integrity test report.
Test Case OQ-DB-03: Differential Pressure Alarms
Objective: To verify the functionality of differential pressure alarms.
Procedure: Simulate conditions that would trigger the DP alarms and confirm activation.
Acceptance Criteria: Alarms must activate at the specified thresholds.
Evidence: Alarm test logs.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A report outlining the nature of the deviation, impact assessment, and corrective actions must be submitted to QA for approval.
Approvals
This protocol must be reviewed and approved by the Quality Assurance team before execution. All results must also be reviewed and approved upon completion of the qualification activities.