Performance Qualification Protocol for Air Classifier Mill in Solid Dosage Form Production
Document Number: PQ-ACM-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to demonstrate that the Air Classifier Mill operates consistently and meets the specified performance criteria in a controlled environment.
Scope
This protocol applies to the Air Classifier Mill used in the production of solid dosage forms within the milling area. It encompasses the evaluation of critical parameters impacting product quality.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with regulatory standards. The Quality Assurance team will review and approve the final report.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary equipment and materials for testing.
- Training of personnel on the operation of the Air Classifier Mill.
Equipment Description
The Air Classifier Mill is designed for controlled fine milling of solid dosage forms. It utilizes a classifier to achieve the desired particle size distribution (PSD) while maintaining product integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Measure classifier speed | Within specified range per URS | Calibration records |
| PQ-02 | Measure airflow | Within specified range per URS | Calibration records |
| PQ-03 | Measure PSD | Meets specifications outlined in URS | Particle size analysis report |
Detailed Test Cases
Test Case PQ-01: Classifier Speed
Procedure: Set the mill to operational conditions and record the classifier speed using calibrated equipment. Compare against URS specifications.
Test Case PQ-02: Airflow Measurement
Procedure: Measure the airflow during operation using calibrated instruments. Ensure it is within the acceptable range defined in the URS.
Test Case PQ-03: Particle Size Distribution
Procedure: Collect samples during operation and analyze the PSD using appropriate analytical methods. Confirm results align with URS specifications.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A formal deviation report should be generated and approved by the Quality Assurance team.
Approvals
By signing below, the following individuals acknowledge their review and approval of this Performance Qualification Protocol:
Validation Team Lead: ______________________ Date: ___________
Quality Assurance Manager: ______________________ Date: ___________