Performance Qualification Protocol for Fitz Mill in Solid Dosage Form Production
Document Number: PQ-FM-001
Version: 1.0
Effective Date: YYYY-MM-DD
Review Date: YYYY-MM-DD
Prepared By: [Name]
Approved By: [Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Fitz Mill for size reduction in the production of solid dosage forms, ensuring it meets the specified acceptance criteria outlined in the User Requirements Specification (URS).
Scope
This protocol applies to the Fitz Mill located in the Production/Milling area and covers the execution of performance qualification testing to confirm the equipment’s capability to operate within defined parameters.
Responsibilities
- Validation Team: Responsible for the execution of the PQ protocol and documentation of results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Personnel: Responsible for assisting in the execution of the PQ tests.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary materials and equipment for testing.
- Training of personnel on the use of the Fitz Mill.
Equipment Description
The Fitz Mill, also known as a comminuting mill, is designed for size reduction in solid dosage forms. It operates by utilizing a high-speed rotor and screen combination to achieve the desired particle size distribution (PSD).
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-FM-01 | Measure speed and document RPM. | RPM within specified range as per URS. | Calibration records, test logs. |
| PQ-FM-02 | Perform particle size distribution (PSD) analysis. | PSD meets specifications outlined in URS. | PSD analysis report. |
Detailed Test Cases
Test Case 1: Speed Measurement
Objective: To verify that the Fitz Mill operates at the specified speed.
Procedure: Measure the RPM of the Fitz Mill during operation using a calibrated tachometer.
Acceptance Criteria: RPM must be within the range specified in the URS.
Expected Outcome: RPM reading is within the acceptable range.
Test Case 2: Particle Size Distribution Analysis
Objective: To confirm the Fitz Mill produces a consistent particle size distribution.
Procedure: Collect samples from the output of the Fitz Mill and analyze using a laser diffraction particle size analyzer.
Acceptance Criteria: PSD results must align with the specifications outlined in the URS.
Expected Outcome: PSD results are consistent with URS specifications.
Deviations
Any deviations from the protocol must be documented and justified. A deviation report should be completed for any test that does not meet the acceptance criteria.
Approvals
Prepared By: ________________________ Date: _______________
Approved By: ________________________ Date: _______________