Document ID: IQ-DMTS-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Installation Qualification Protocol for Dose Metering Test System
Objective: To verify that the Dose Metering Test System is installed correctly and operates in accordance with the specified requirements for nasal and otic product validation.
Scope: This protocol applies to the Installation Qualification of the Dose Metering Test System utilized in the QC/Production area for nasal and otic products.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Maintenance Team: Responsible for ensuring the system is installed and maintained according to specifications.
Prerequisites:
- Completion of equipment installation.
- Availability of relevant documentation (URS, equipment manuals).
- Training of personnel on the use of the equipment.
Equipment Description: The Dose Metering Test System is an instrument designed to verify the delivered dose and spray characteristics of nasal and otic products. It evaluates dose uniformity, spray geometry, and maintains an audit trail for compliance.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify equipment installation as per manufacturer’s specifications. | Installation meets all specified requirements. | Installation checklist signed off by maintenance. |
| IQ-02 | Check calibration of the system using standard solutions. | Calibration within specified limits. | Calibration report. |
| IQ-03 | Review software and firmware versions. | Versions match those specified in URS. | Software version log. |
| IQ-04 | Verify audit trail functionality. | Audit trail captures all relevant transactions. | Audit trail report. |
Detailed Test Cases:
- Test ID: IQ-01
- Procedure: Confirm all components are installed according to the layout diagram.
- Acceptance Criteria: All components are present and correctly positioned.
- Evidence: Photographic documentation and installation checklist.
- Test ID: IQ-02
- Procedure: Use standard solutions to calibrate the system.
- Acceptance Criteria: Calibration results must fall within specified limits.
- Evidence: Calibration report with results.
- Test ID: IQ-03
- Procedure: Review the software version against the specified version in URS.
- Acceptance Criteria: Version matches.
- Evidence: Software version log.
- Test ID: IQ-04
- Procedure: Test the audit trail for accuracy and completeness.
- Acceptance Criteria: All actions are logged correctly.
- Evidence: Audit trail report.
Deviations: Any deviations from the acceptance criteria must be documented and addressed according to the deviation management procedure.
Approvals:
- Prepared by: ____________________ Date: ___________
- Reviewed by: ____________________ Date: ___________
- Approved by: ____________________ Date: ___________
Data Integrity Checks: Ensure all data entries are logged with timestamps, user identification, and are backed up regularly to prevent data loss.