Document Number: IQ-TRS-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Installation Qualification Protocol for the Solvent Recovery System
Objective: To ensure that the Solvent Recovery System is installed correctly and operates as intended to recover solvents from the drying process of transdermal patches.
Scope: This protocol applies to the Installation Qualification of the Solvent Recovery System located in the production area for the manufacturing of transdermal patches.
Responsibilities:
- Validation Team: Prepare and execute the IQ protocol.
- Engineering Team: Support installation and provide necessary documentation.
- Quality Assurance: Review and approve the IQ protocol and results.
Prerequisites:
- Completion of equipment installation.
- Availability of operation manuals and specifications.
- Training of personnel on the use of the equipment.
Equipment Description: The Solvent Recovery System is designed to recover solvents used during the drying process of transdermal patches. It operates under controlled temperature and pressure conditions to ensure optimal solvent recovery efficiency.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation against the approved URS. | All components must match specifications outlined in URS Annex 11. | Installation checklist signed by responsible personnel. |
| IQ-02 | Check temperature settings and calibration. | Temperature must be within specified range. | Calibration certificate and temperature logs. |
| IQ-03 | Check pressure settings and calibration. | Pressure must be within specified range. | Calibration certificate and pressure logs. |
| IQ-04 | Evaluate solvent recovery efficiency. | Efficiency must meet established benchmarks. | Efficiency report generated post-testing. |
| IQ-05 | Validate audit trail functionality. | Audit trail must be complete and accessible. | Audit trail report from the system. |
Detailed Test Cases:
- Test ID: IQ-01 – Confirm that all equipment components are installed according to specifications. Document any discrepancies.
- Test ID: IQ-02 – Measure the temperature using calibrated equipment. Document readings against acceptance criteria.
- Test ID: IQ-03 – Measure the pressure using calibrated equipment. Document readings against acceptance criteria.
- Test ID: IQ-04 – Conduct solvent recovery operations and calculate efficiency. Document results and compare with benchmarks.
- Test ID: IQ-05 – Access the audit trail and verify that all entries are complete and accurate. Document findings.
Deviations: Any deviations from the acceptance criteria must be documented in the deviation log, including the nature of the deviation, investigation, and corrective actions taken.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Engineering Manager: ___________________ Date: ___________
- Quality Assurance Manager: _______________ Date: ___________