Installation Qualification Protocol for Roller Compactor in Dry Granulation
Document Number: IQ-001
Revision: 1.0
Date: 2023-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Roller Compactor is installed correctly and operates according to the specified requirements for dry granulation processes.
Scope
This protocol applies to the Roller Compactor utilized in the production area for dry granulation of solid dosage forms. It covers the installation and operational aspects necessary for compliance with regulatory requirements.
Responsibilities
The Validation Team is responsible for executing this protocol. The Equipment Owner is responsible for ensuring that the Roller Compactor is maintained and operated according to the defined procedures.
Prerequisites
All personnel involved in the execution of this protocol must have completed training in equipment operation and validation procedures. The Roller Compactor must be installed in accordance with the manufacturer’s specifications.
Equipment Description
The Roller Compactor is designed for dry granulation processes, featuring adjustable roll pressure, gap, speed, and feed rate. It is critical for ensuring uniformity and consistency in the granulation of solid dosage forms.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-001 | Verify installation of Roller Compactor components | All components installed as per manufacturer specifications | Installation checklist |
| IQ-002 | Check electrical connections and PLC setup | PLC configured correctly and operational | PLC configuration report |
| IQ-003 | Test roll pressure and gap settings | Roll pressure and gap within specified limits | Calibration report |
| IQ-004 | Verify speed and feed rate settings | Speed and feed rate meet operational specifications | Operational verification log |
Detailed Test Cases
Test ID: IQ-001
Procedure: Verify installation of Roller Compactor components.
Acceptance Criteria: All components installed as per manufacturer specifications.
Evidence: Installation checklist.
Test ID: IQ-002
Procedure: Check electrical connections and PLC setup.
Acceptance Criteria: PLC configured correctly and operational.
Evidence: PLC configuration report.
Test ID: IQ-003
Procedure: Test roll pressure and gap settings.
Acceptance Criteria: Roll pressure and gap within specified limits.
Evidence: Calibration report.
Test ID: IQ-004
Procedure: Verify speed and feed rate settings.
Acceptance Criteria: Speed and feed rate meet operational specifications.
Evidence: Operational verification log.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A corrective action plan will be developed for any critical deviations identified during the IQ process.
Approvals
This protocol must be approved by the Validation Manager and the Quality Assurance department prior to execution.
Data Integrity Checks
Ensure that all data recorded during the IQ process is securely stored and backed up. Implement checks to verify that data is not altered post-recording, and maintain audit trails for all electronic records.