Document Control
Document ID: PQ-DB-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed by: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Dispensing Booth in API Manufacturing
Meta Description: This document outlines the Performance Qualification (PQ) protocol for the Dispensing Booth used in API manufacturing, focusing on critical parameters and acceptance criteria.
Tags: Performance Qualification, Equipment Validation, API Manufacturing, Dispensing Booth
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Dispensing Booth used for weighing API raw materials, ensuring it meets the necessary acceptance criteria for critical parameters.
Scope
This protocol applies to the Dispensing Booth located in the Production/Dispensing area for API manufacturing. It encompasses the validation of critical parameters affecting product quality.
Responsibilities
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Personnel: Ensure proper operation of the Dispensing Booth during testing.
Prerequisites
- Completion of Installation Qualification (IQ) for the Dispensing Booth.
- Availability of necessary equipment and materials for testing.
- Training of personnel on the operation of the Dispensing Booth.
Equipment Description
The Dispensing Booth is a controlled environment system designed for weighing API raw materials. It features HEPA filtration, adjustable air velocity, and alarms for differential pressure (DP) integrity.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| TP-01 | Measure air velocity at various points inside the booth. | Air velocity within specified limits (as per URS). | Air velocity measurement logs. |
| TP-02 | Perform HEPA filter integrity test. | Pass integrity test as per ISO14644. | HEPA integrity test report. |
| TP-03 | Check differential pressure alarms functionality. | Alarms activate within specified limits. | Alarm test logs. |
Detailed Test Cases
Test Case 1: Air Velocity Measurement
Objective: To ensure the air velocity is within the acceptable limits.
Procedure: Use a calibrated anemometer to measure air velocity at designated points inside the booth.
Acceptance Criteria: Air velocity should be between [Insert Acceptable Range].
Expected Results: All measurements should fall within the specified range.
Test Case 2: HEPA Filter Integrity Test
Objective: To verify the integrity of the HEPA filter.
Procedure: Conduct a DOP test using a suitable aerosol generator.
Acceptance Criteria: No leaks detected; integrity maintained.
Expected Results: Test results should confirm filter integrity.
Test Case 3: Differential Pressure Alarm Functionality
Objective: To ensure the differential pressure alarms function correctly.
Procedure: Simulate conditions to test alarm activation.
Acceptance Criteria: Alarms activate at predetermined DP thresholds.
Expected Results: Alarms should activate as specified.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be developed as necessary.
Approvals
Approved by: [Insert Name]
Title: [Insert Title]
Date: [Insert Date]