Document Control Number: IQ-OSD-TCW-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Inline Tablet Checkweigher
Objective: To ensure the installation of the Inline Tablet Checkweigher meets specified requirements for weight verification in the production of solid dosage forms, ensuring compliance with regulatory standards.
Scope: This protocol applies to the installation qualification of the Inline Tablet Checkweigher used in the Production/Compression area for weight verification of solid dosage forms.
Responsibilities:
- Validation Team: Responsible for protocol execution and documentation.
- Quality Assurance: Responsible for review and approval of the protocol.
- Maintenance Team: Responsible for equipment setup and maintenance.
Prerequisites:
- Completion of equipment installation.
- Availability of necessary documentation (URS, SOPs, etc.).
- Training of personnel on equipment operation.
Equipment Description:
The Inline Tablet Checkweigher is designed for weight verification of tablets during the production process. It features an accuracy reject mechanism and an audit trail for compliance with regulatory standards.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-TCW-01 | Verify installation against manufacturer specifications. | All components installed as per specifications. | Installation checklist signed off. |
| IQ-TCW-02 | Check functionality of accuracy reject mechanism. | Reject mechanism functions correctly for out-of-spec weights. | Test results logged in the system. |
| IQ-TCW-03 | Audit trail verification. | Audit trail captures all weight verifications and rejects. | Audit trail report generated and reviewed. |
Detailed Test Cases:
Test Case: IQ-TCW-01
Objective: Verify installation against manufacturer specifications.
Procedure: Inspect all components and compare with the manufacturer’s installation guide.
Acceptance Criteria: All components installed as per specifications.
Evidence: Installation checklist signed off by validation team.
Test Case: IQ-TCW-02
Objective: Check functionality of accuracy reject mechanism.
Procedure: Perform tests using calibrated weights to verify the reject mechanism.
Acceptance Criteria: Reject mechanism functions correctly for out-of-spec weights.
Evidence: Test results logged in the system.
Test Case: IQ-TCW-03
Objective: Audit trail verification.
Procedure: Review the audit trail for completeness and accuracy.
Acceptance Criteria: Audit trail captures all weight verifications and rejects.
Evidence: Audit trail report generated and reviewed.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed if necessary.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Quality Assurance Manager: ______________ Date: ___________
- Maintenance Supervisor: _________________ Date: ___________
Data Integrity Checks:
- Ensure all data entries are time-stamped and attributed to the responsible personnel.
- Regular audits of the audit trail to ensure compliance and accuracy.
- Backup of data to prevent loss and ensure traceability.