Document Control Number: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Performance Qualification Protocol for Jet Mill in Inhaled NDDS Powders
Objective
The objective of this Performance Qualification (PQ) protocol is to demonstrate that the Jet Mill/Spiral Mill operates consistently and produces inhaled NDDS powders that meet predefined specifications.
Scope
This protocol applies to the validation of Jet Mill/Spiral Mill equipment used in the R&D and Production areas for micronizing Active Pharmaceutical Ingredients (APIs) for inhalation.
Responsibilities
The Validation Team is responsible for executing this protocol, ensuring compliance with regulatory requirements, and documenting results. The Quality Assurance (QA) team will review and approve the protocol and results.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of required materials and equipment.
- Training of personnel on the equipment operation.
Equipment Description
The Jet Mill/Spiral Mill is designed to micronize APIs for inhalation, ensuring controlled particle size distribution (PSD) with minimal contamination. The equipment operates under controlled pressure and feed rates.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify pressure feed rate during operation. | Within specified operational limits. | Pressure readings log. |
| PQ-02 | Measure particle size distribution (PSD). | Meets specifications outlined in URS. | PSD analysis report. |
| PQ-03 | Assess containment levels during operation. | No detectable emissions outside the system. | Containment monitoring report. |
Detailed Test Cases
Test Case PQ-01: Pressure Feed Rate Verification
Procedure: Record the pressure feed rate during normal operation over a defined period.
Acceptance Criteria: Pressure readings must remain within the specified operational limits.
Evidence: Documented pressure readings logged in the equipment’s operational log.
Test Case PQ-02: Particle Size Distribution Measurement
Procedure: Collect samples of micronized API and analyze for PSD using appropriate analytical methods.
Acceptance Criteria: PSD must meet specifications outlined in the User Requirements Specification (URS).
Evidence: PSD analysis report generated by the analytical laboratory.
Test Case PQ-03: Containment Assessment
Procedure: Monitor emissions during operation to assess containment effectiveness.
Acceptance Criteria: No detectable emissions should be observed outside the system.
Evidence: Containment monitoring report detailing results of the assessment.
Deviations
Any deviations from the protocol must be documented and justified. All deviations will be reviewed and approved by the QA team.
Approvals
Prepared by: [Name], Validation Team
Reviewed by: [Name], Quality Assurance
Approved by: [Name], Department Head