Document Number: IQ-HSG-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Installation Qualification Protocol for High Shear Granulator
This document outlines the Installation Qualification (IQ) protocol for the High Shear Granulator (HSG) used in wet granulation processes.
Objective: To ensure that the High Shear Granulator is installed according to specifications and is suitable for its intended use in the production of solid dosage forms.
Scope: This protocol applies to the High Shear Granulator located in the Production/Granulation area and covers all installation aspects related to equipment validation.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol.
- Quality Assurance: Responsible for reviewing and approving the protocol.
- Maintenance Team: Responsible for equipment installation and initial setup.
Prerequisites:
- Completion of the equipment purchase and receipt process.
- Verification of installation site conditions.
- Availability of necessary documentation (URS, specifications).
Equipment Description: The High Shear Granulator is designed for wet granulation processes, featuring precise control over critical parameters such as speed, time, torque, and binder addition through a PLC system. It is classified as critical due to its direct impact on product quality.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify equipment installation according to manufacturer’s specifications. | All components must be installed as per the installation manual. | Installation checklist signed by the maintenance team. |
| IQ-02 | Check the functionality of the PLC system. | The PLC must operate without errors and control all parameters. | PLC functionality test report. |
| IQ-03 | Validate critical parameter settings (speed, time, torque, binder addition). | Settings must match specified values in the URS Annex11. | Parameter validation report. |
Detailed Test Cases:
-
Test Case ID: TC-IQ-01
Description: Verify that the equipment is level and properly anchored.
Expected Result: Equipment must be stable and secured. -
Test Case ID: TC-IQ-02
Description: Confirm electrical connections are secure and compliant.
Expected Result: All electrical connections must be intact and meet safety standards. -
Test Case ID: TC-IQ-03
Description: Test the emergency stop function.
Expected Result: Emergency stop must halt all operations immediately.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on the validation process. A deviation report must be generated for any non-conformance.
Approvals:
- Validation Team Lead: ___________________ Date: __________
- Quality Assurance: ___________________ Date: __________
Data Integrity Checks:
- Ensure all data logged by the PLC is timestamped and securely stored.
- Conduct periodic audits of data integrity to confirm compliance with regulatory standards.
- Implement access controls to prevent unauthorized modifications to critical parameters.