Document ID: PQ-RMG-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed by: [Name]
Approved by: [Name]
Performance Qualification Protocol for Rapid Mixer Granulator
This document outlines the Performance Qualification (PQ) protocol for the Rapid Mixer Granulator (RMG) used in the production of solid dosage forms through wet granulation.
Objective: To ensure that the Rapid Mixer Granulator operates within specified parameters and meets the acceptance criteria defined in the User Requirement Specification (URS) Annex 11.
Scope: This protocol applies to the PQ of the RMG utilized in the production area for wet granulation processes impacting product quality directly.
Responsibilities:
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the PQ documentation.
- Production Team: Ensure equipment is set up and maintained as per protocol requirements.
Prerequisites:
- Equipment installation and operational qualification completed.
- All personnel trained on equipment operation and safety procedures.
- Availability of necessary materials and resources for testing.
Equipment Description:
The Rapid Mixer Granulator (RMG) is designed for wet granulation processes, featuring adjustable impeller and chopper speeds, torque measurement, and PLC-controlled alarms for monitoring critical parameters.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-RMG-01 | Verify impeller speed settings during operation. | Speed within specified range as per URS Annex 11. | Calibration records and operation logs. |
| PQ-RMG-02 | Measure chopper speed during granulation. | Chopper speed within defined limits as per URS Annex 11. | Operational data logs. |
| PQ-RMG-03 | Monitor torque during operation. | Torque readings within specified thresholds. | Torque measurement records. |
| PQ-RMG-04 | Check PLC alarms functionality. | All critical alarms activate as per URS Annex 11. | Alarm test logs. |
Detailed Test Cases:
- Test Case ID: PQ-RMG-01
Objective: To verify that the impeller speed is set correctly.
Procedure: Start the RMG and adjust the impeller speed to the specified set-point. Record the actual speed.
Expected Result: Impeller speed should match the set-point within the defined range. - Test Case ID: PQ-RMG-02
Objective: To ensure the chopper speed is within the acceptable range.
Procedure: Monitor chopper speed during granulation and record values.
Expected Result: Chopper speed should remain within the specified limits. - Test Case ID: PQ-RMG-03
Objective: To confirm torque readings are within acceptable parameters.
Procedure: Measure torque during operation and document readings.
Expected Result: Torque should be within specified thresholds. - Test Case ID: PQ-RMG-04
Objective: To verify that all PLC alarms function correctly.
Procedure: Simulate alarm conditions and confirm activation.
Expected Result: All critical alarms should activate as intended.
Deviations: Any deviation from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be defined and implemented.
Approvals:
- Prepared by: [Name] – [Title]
- Reviewed by: [Name] – [Title]
- Approved by: [Name] – [Title]
Data Integrity Checks: Ensure all data logged during the PQ is backed up and stored securely. Regular audits should be performed to verify data accuracy and integrity.