Document Control
Document ID: IQ-CB-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Installation Qualification Protocol for Continuous Blender
This document outlines the Installation Qualification (IQ) protocol for the Continuous Blender used in the production of solid dosage forms.
Objective: To ensure that the Continuous Blender is installed correctly and operates according to the specified requirements, thereby confirming its suitability for production use.
Scope: This protocol applies to the Continuous Blender utilized in the Production/Continuous Manufacturing area for solid dosage forms.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the completed protocol.
- Operations: Responsible for providing access to the equipment and necessary documentation.
Prerequisites:
- Installation of Continuous Blender completed.
- All utilities (electricity, water, etc.) connected and functioning.
- Staff trained on equipment operation and safety protocols.
Equipment Description:
The Continuous Blender is designed for continuous blending of solid dosage forms. It features advanced PLC controls and is critical for maintaining product quality.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-CB-01 | Verify installation of Continuous Blender components. | All components installed per manufacturer’s specifications. | Installation checklist signed off. |
| IQ-CB-02 | Check utility connections (electricity, water). | Utilities connected and operational. | Utility connection report. |
| IQ-CB-03 | Verify functionality of PLC controls. | PLC controls operate as intended. | PLC functionality test report. |
| IQ-CB-04 | Confirm feed rates and RTD RPM settings. | Feed rates and RTD RPM within specified limits. | Feed rate and RPM verification log. |
Detailed Test Cases:
- Test ID: IQ-CB-01 – Verify installation of Continuous Blender components.
- Procedure: Inspect all components per the installation manual.
- Acceptance Criteria: All components must be installed according to specifications.
- Evidence: Installation checklist must be signed and dated.
- Test ID: IQ-CB-02 – Check utility connections.
- Procedure: Verify that all utilities are connected and operational.
- Acceptance Criteria: All utilities must be functional.
- Evidence: Utility connection report must be available.
- Test ID: IQ-CB-03 – Verify PLC functionality.
- Procedure: Test PLC controls for proper operation.
- Acceptance Criteria: PLC must operate within specified parameters.
- Evidence: PLC functionality test report must be documented.
- Test ID: IQ-CB-04 – Confirm feed rates and RTD RPM.
- Procedure: Measure and record feed rates and RTD RPM settings.
- Acceptance Criteria: Values must meet predetermined specifications.
- Evidence: Verification log must be completed and signed.
Deviations: Any deviations from the acceptance criteria must be documented in the deviation report and addressed accordingly.
Approvals:
- Validation Team Lead: ___________________ Date: __________
- Quality Assurance: ___________________ Date: __________
Data Integrity Checks:
- Ensure all data entries are timestamped and user-logged in the PLC system.
- Regular audits of the data logs for accuracy and completeness.
- Implement access controls to ensure only authorized personnel can modify settings.