Document Control Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Particle Size Classification System
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Particle Size Classification System used for size fraction selection in the production of microspheres and microcapsules.
Scope
This protocol applies to the Particle Size Classification System utilized in the R&D and Production areas for the classification of microspheres and microcapsules.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Equipment Owner: Responsible for ensuring the equipment is maintained and calibrated.
Prerequisites
Before executing this protocol, the following prerequisites must be met:
- Equipment must be calibrated and in good working condition.
- All personnel must be trained on the use of the Particle Size Classification System.
- Relevant Standard Operating Procedures (SOPs) for operation must be available.
Equipment Description
The Particle Size Classification System consists of sieves and an air classifier designed to separate particles based on size, ensuring the integrity of the size fractions selected for microspheres and microcapsules.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify sieve integrity and cut size. | Sieve cut size must match URS specifications. | Calibration certificate, inspection logs. |
| PQ-02 | Conduct particle size distribution analysis. | Results must fall within specified ranges. | Test results report. |
Detailed Test Cases
Test Case PQ-01: Verify Sieve Integrity and Cut Size
1. Inspect the sieves for any physical damage or wear.
2. Measure the cut size using calibrated measurement tools.
3. Document findings and compare against URS specifications.
Test Case PQ-02: Conduct Particle Size Distribution Analysis
1. Perform particle size analysis using the Particle Size Classification System.
2. Record the distribution of particle sizes.
3. Compare results to predetermined acceptance criteria.
Deviations
Any deviations from the protocol must be documented and justified. A deviation report must be submitted for review and approval.
Approvals
Approved by: ______________________
Date: ______________________
Quality Assurance Review: ______________________
Date: ______________________
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