Document Control
Document Number: PQ-DB-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Performance Qualification Protocol for Dispensing Booth in Solid Dosage Form Production
Meta Description: This document outlines the Performance Qualification protocol for a Dispensing Booth used in Solid Dosage Form production, ensuring compliance with industry standards.
Tags: Equipment Validation, Performance Qualification, Dispensing Booth, OSD, Pharmaceutical Compliance
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Dispensing Booth operates according to specified requirements and meets the necessary performance criteria for weighing and dispensing under containment conditions.
Scope
This protocol applies to the Dispensing Booth (Downflow) utilized in the Production/Dispensing area for Solid Dosage Form (OSD) operations. It encompasses the assessment of critical parameters impacting product quality.
Responsibilities
The following personnel are responsible for the execution and oversight of this protocol:
- Validation Team: Overall execution and documentation.
- Quality Assurance: Review and approval of the protocol and results.
- Production Personnel: Operation of the Dispensing Booth during testing.
Prerequisites
- Completion of Installation Qualification (IQ) for the Dispensing Booth.
- Training of personnel on the operation of the equipment.
- Availability of necessary testing equipment and materials.
Equipment Description
The Dispensing Booth (Downflow) is designed for the containment of powders during weighing and dispensing processes. It features HEPA filtration, air velocity monitoring, and differential pressure alarms to ensure a controlled environment.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Measure air velocity at the booth’s work surface. | Air velocity between 0.5 – 1.0 m/s. | Air velocity log sheet. |
| PQ-02 | Perform HEPA integrity test. | Pass criteria as per ISO 14644. | HEPA test report. |
| PQ-03 | Check differential pressure alarms functionality. | Alarms activate at set points. | Alarm test report. |
Detailed Test Cases
Test Case PQ-01: Air Velocity Measurement
1. Position the anemometer at the work surface of the Dispensing Booth.
2. Record the air velocity readings at multiple points.
3. Compare results against acceptance criteria.
Test Case PQ-02: HEPA Integrity Test
1. Conduct a HEPA filter integrity test using appropriate methods.
2. Document results and ensure they meet ISO 14644 standards.
Test Case PQ-03: Differential Pressure Alarm Functionality
1. Simulate conditions that would trigger the differential pressure alarm.
2. Verify that alarms activate appropriately and are audible/visible.
Deviations
Any deviations from the protocol must be documented, including the reason for the deviation and any impact on the results. Approval from Quality Assurance is required for any changes.
Approvals
Approved by: [Insert Name], Quality Assurance
Date: [Insert Date]
Approved by: [Insert Name], Validation Team Lead
Date: [Insert Date]