Document Control:
Document Number: IQ-CM-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Conductivity Meter
Objective: This protocol outlines the Installation Qualification (IQ) for the Conductivity Meter used in the QC Laboratory to ensure that the equipment is installed correctly and is functioning per the specified requirements.
Scope: This protocol applies to the Conductivity Meter utilized in the QC Laboratory for conductivity measurement, impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
- Laboratory Personnel: Responsible for operating the equipment and reporting any discrepancies.
Prerequisites:
- Installation of Conductivity Meter completed.
- All relevant training for personnel completed.
- Availability of all necessary documentation (URS, SOPs, etc.).
Equipment Description:
The Conductivity Meter is an instrument used for measuring the electrical conductivity of liquids, providing critical data for quality control in pharmaceutical manufacturing.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation location and environmental conditions. | Installation meets specified environmental conditions. | Installation checklist. |
| IQ-02 | Check power supply and connectivity. | Power supply is stable and within specified voltage range. | Power supply log. |
| IQ-03 | Perform accuracy calibration audit trail check. | Calibration meets accuracy specifications. | Calibration certificate. |
Detailed Test Cases:
- Test Case IQ-01: Inspect the installation site for compliance with environmental requirements.
- Test Case IQ-02: Measure voltage using a multimeter to ensure power supply is within range.
- Test Case IQ-03: Review calibration records to confirm that the meter has been calibrated according to the schedule and specifications.
Data Integrity Checks:
- Ensure that all calibration data is logged with timestamps.
- Verify that audit trails are maintained for all adjustments made to the meter.
- Confirm that access to calibration settings is restricted to authorized personnel only.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be initiated if necessary.
Approvals:
Validation Team Lead: ____________________ Date: ___________
Quality Assurance Manager: _______________ Date: ___________