Document Control
Document Title: Operational Qualification Protocol for Sampling Booth
Category: Equipment Validation
Subcategory: Solid Dosage Form (OSD)
Version: 1.0
Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Operational Qualification Protocol for Sampling Booth in Solid Dosage Form Production
Meta Description: This document outlines the Operational Qualification protocol for a Sampling Booth used in Solid Dosage Form production, focusing on raw material sampling under containment.
Tags: Equipment Validation, Operational Qualification, Sampling Booth, OSD, Pharmaceutical Industry
Objective
The objective of this protocol is to establish documented evidence that the Sampling Booth operates according to the specified requirements and is suitable for its intended use in raw material sampling under containment.
Scope
This protocol applies to the Operational Qualification of the Sampling Booth (Downflow/RLAF) used in the Production/Sampling area for the direct impact on product quality.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Maintenance Team: Responsible for ensuring the equipment is maintained and calibrated prior to testing.
Prerequisites
- Completion of Installation Qualification (IQ).
- Calibration of all relevant equipment.
- Availability of necessary tools and materials for testing.
Equipment Description
The Sampling Booth (Downflow/RLAF) is designed to provide a controlled environment for raw material sampling while ensuring containment. It features HEPA filtration, air velocity monitoring, and differential pressure alarms to maintain product integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Measure air velocity at designated points. | Air velocity must be within 0.45 m/s to 0.75 m/s. | Velocity measurement logs. |
| OQ-002 | Perform HEPA integrity test. | HEPA filter must maintain integrity with no leaks. | Test results report. |
| OQ-003 | Check differential pressure alarms functionality. | DP alarms must activate within specified limits. | Alarm test logs. |
Detailed Test Cases
Test Case OQ-001: Air Velocity Measurement
Objective: To verify the air velocity in the Sampling Booth.
Procedure: Use an anemometer to measure air velocity at 5 designated points within the booth.
Acceptance Criteria: Air velocity must be within 0.45 m/s to 0.75 m/s.
Evidence: Record measurements in the logbook.
Test Case OQ-002: HEPA Integrity Test
Objective: To ensure HEPA filter integrity is maintained.
Procedure: Conduct a DOP test to assess HEPA filter performance.
Acceptance Criteria: No leaks detected during testing.
Evidence: Test report documenting results.
Test Case OQ-003: Differential Pressure Alarms
Objective: To confirm alarm functionality for differential pressure.
Procedure: Simulate conditions to test alarm activation.
Acceptance Criteria: Alarms must activate within specified limits.
Evidence: Alarm test log.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A root cause analysis should be conducted, and corrective actions must be implemented.
Approvals
This protocol requires approval from the Quality Assurance department prior to execution. All results must be reviewed and signed off by the responsible parties.