Document Control:
Document Number: IQ-RMG-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Installation Qualification Protocol for Rapid Mixer Granulator (RMG)
Meta Description: This document outlines the Installation Qualification (IQ) protocol for the Rapid Mixer Granulator (RMG) used in solid dosage form production, focusing on wet granulation processes.
Tags: Equipment Validation, RMG, IQ Protocol, Wet Granulation
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Rapid Mixer Granulator (RMG) is installed correctly and operates according to the specified requirements for wet granulation in the production area.
Scope
This protocol applies to the Installation Qualification of the RMG used in the production of solid dosage forms, specifically in the wet granulation process.
Responsibilities
The validation team is responsible for executing the IQ protocol, while the Quality Assurance (QA) department is responsible for reviewing and approving the protocol and its results.
Prerequisites
- Completion of equipment installation.
- Availability of relevant documentation (URS, FS, DS).
- Training of personnel on equipment operation.
Equipment Description
The Rapid Mixer Granulator (RMG) is designed for wet granulation processes in the production of solid dosage forms. It features adjustable impeller and chopper speeds, torque measurement, and PLC alarms for critical parameters.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation of equipment components. | All components installed as per manufacturer specifications. | Installation checklist signed by technician. |
| IQ-02 | Check impeller/chopper speed. | Speed within specified range (e.g., 50-100 RPM). | Calibration report. |
| IQ-03 | Measure torque during operation. | Torque within specified limits. | Torque measurement logs. |
| IQ-04 | Verify PLC alarms functionality. | All alarms function as intended. | Alarm test report. |
Detailed Test Cases
Test Case IQ-01
Objective: To verify the installation of all equipment components.
Procedure: Review installation checklist and confirm all components are present and correctly installed.
Acceptance Criteria: All components installed as per manufacturer specifications.
Evidence: Installation checklist signed by technician.
Test Case IQ-02
Objective: To check the impeller/chopper speed.
Procedure: Start the RMG and measure the speed of the impeller and chopper using a tachometer.
Acceptance Criteria: Speed within specified range (e.g., 50-100 RPM).
Evidence: Calibration report.
Test Case IQ-03
Objective: To measure torque during operation.
Procedure: Operate the RMG and record the torque values displayed on the system.
Acceptance Criteria: Torque within specified limits.
Evidence: Torque measurement logs.
Test Case IQ-04
Objective: To verify the functionality of PLC alarms.
Procedure: Simulate alarm conditions and confirm that alarms activate as expected.
Acceptance Criteria: All alarms function as intended.
Evidence: Alarm test report.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A deviation report should be generated for review and approval.
Approvals
This protocol and its results must be reviewed and approved by the following:
- Validation Manager: ____________________ Date: ___________
- Quality Assurance: ____________________ Date: ___________