Document Control
Document ID: PQ-HM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Performance Qualification Protocol for Hammer Mill in Solid Dosage Form
Objective: To validate the performance of the Hammer Mill used for size reduction in the production of solid dosage forms, ensuring compliance with the User Requirements Specification (URS).
Scope: This protocol applies to the Hammer Mill located in the Production/Milling area and covers all aspects of its operation related to size reduction of solid dosage forms.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Personnel: Responsible for operating the Hammer Mill as per the protocol.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the operation of the Hammer Mill.
- Availability of necessary materials for testing.
Equipment Description:
The Hammer Mill is a high-speed size reduction machine utilized in the production of solid dosage forms. It operates by impacting materials against a series of screens, allowing for controlled particle size distribution.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-HM-01 | Measure speed of the Hammer Mill during operation. | Speed must be within the range specified in the URS. | Calibration records and speed measurement logs. |
| PQ-HM-02 | Evaluate screen output for particle size distribution (PSD). | PSD must meet specifications outlined in the URS. | PSD analysis report. |
| PQ-HM-03 | Monitor heat generation during operation. | Heat must not exceed limits set forth in the URS. | Temperature logs and monitoring records. |
Test Cases
Test Case 1: Speed Measurement
Procedure: The speed of the Hammer Mill will be measured using a calibrated tachometer during normal operation. The recorded speed will be compared against the URS specifications.
Acceptance Criteria: Speed must be within the specified range.
Evidence: Speed measurement logs will be documented and reviewed.
Test Case 2: Particle Size Distribution (PSD) Analysis
Procedure: Samples will be collected from the Hammer Mill output and analyzed for PSD using a laser diffraction method.
Acceptance Criteria: PSD must conform to the specifications in the URS.
Evidence: PSD analysis report will be generated and reviewed.
Test Case 3: Heat Monitoring
Procedure: The temperature of the Hammer Mill will be monitored continuously during operation using temperature sensors.
Acceptance Criteria: Temperature must not exceed the limits defined in the URS.
Evidence: Temperature logs will be maintained and reviewed.
Deviations
Any deviations from the acceptance criteria must be documented, including the nature of the deviation, the impact on the product, and any corrective actions taken.
Approvals
By signing this document, the following individuals approve the Performance Qualification protocol:
______________________ Prepared by
______________________ Approved by