Document Control Number: IQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Installation Qualification Protocol for Screw Capper in Solid Dosage Form
Objective: To establish and document the installation qualification of the Screw Capper to ensure it operates within specified parameters and meets regulatory requirements.
Scope: This protocol applies to the installation qualification of the Screw Capper used in the packaging of solid dosage forms, specifically for capping bottles.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ documentation.
- Maintenance Team: Responsible for ensuring the equipment is installed correctly and meets operational specifications.
Prerequisites:
- Completion of equipment installation by the maintenance team.
- Availability of relevant operation manuals and standard operating procedures.
- Training of personnel on equipment operation and safety protocols.
Equipment Description:
The Screw Capper is designed for capping bottles in the packaging of solid dosage forms. It utilizes torque range, speed adjustments, reject sensors, and maintains an audit trail for compliance and traceability.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify equipment installation according to manufacturer’s specifications. | All installation components must match specifications. | Installation checklist signed by maintenance. |
| IQ-02 | Check torque range settings. | Torque must be within specified range. | Calibration logs and settings printout. |
| IQ-03 | Test speed settings. | Speed must meet operational specifications. | Speed test results documentation. |
| IQ-04 | Verify reject sensors functionality. | All reject sensors must activate correctly. | Sensor test results. |
| IQ-05 | Audit trail verification. | Audit trail must log all operations accurately. | Audit trail report. |
Detailed Test Cases:
- Test ID: IQ-01
- Procedure: Confirm all components are installed as per the installation manual.
- Acceptance Criteria: All components should be present and correctly installed.
- Evidence: Completed installation checklist.
- Test ID: IQ-02
- Procedure: Measure and record the torque settings using calibrated tools.
- Acceptance Criteria: Torque settings must be within the specified range.
- Evidence: Calibration logs.
- Test ID: IQ-03
- Procedure: Adjust and measure speed settings during operation.
- Acceptance Criteria: Speed must meet the operational parameters.
- Evidence: Speed measurement documentation.
- Test ID: IQ-04
- Procedure: Perform functional tests on reject sensors.
- Acceptance Criteria: All sensors must respond correctly to simulated failures.
- Evidence: Test results for reject sensors.
- Test ID: IQ-05
- Procedure: Review the audit trail for accuracy and completeness.
- Acceptance Criteria: Audit trail must log all operational events accurately.
- Evidence: Audit trail report.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be implemented as necessary.
Approvals:
- Validation Team Lead: ______________________ Date: ___________
- Quality Assurance Manager: ______________________ Date: ___________
- Maintenance Supervisor: ______________________ Date: ___________
Data Integrity Checks: Ensure that all data recorded during the IQ process is backed up and stored securely. Implement checks to verify that no data has been altered or deleted post-recording.