Installation Qualification Protocol for Ophthalmic Sterile Filtration Skid
Document Control Number: IQ-OSFS-001
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Insert Name]
Reviewed by: [Insert Name]
Approved by: [Insert Name]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Ophthalmic Sterile Filtration Skid is installed correctly and operates according to its intended use for sterilizing filtration in the production of sterile eye drops and ointments.
Scope
This protocol applies to the Installation Qualification of the Ophthalmic Sterile Filtration Skid located in the Production area. It encompasses the verification of installation, functionality, and critical parameters as per the User Requirements Specification (URS) and relevant regulatory guidelines.
Responsibilities
The following personnel are responsible for the execution and documentation of this protocol:
- Validation Team: Responsible for executing the IQ protocol.
- Quality Assurance: Responsible for reviewing and approving the protocol.
- Engineering: Responsible for the installation and maintenance of the equipment.
Prerequisites
Before executing this protocol, the following prerequisites must be met:
- Equipment installation completed as per manufacturer’s specifications.
- All relevant documentation (URS, specifications, etc.) available for review.
- Training of personnel on equipment operation and validation processes.
Equipment Description
The Ophthalmic Sterile Filtration Skid is designed for the sterilizing filtration of sterile eye drops and ointments. It utilizes a 0.22 µm filtration membrane to ensure the removal of microorganisms. The system includes the following components:
- Filtration unit with integrity testing capability.
- Piping and valves for fluid transfer.
- Control system with data logging and audit trail functionality.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation against manufacturer specifications. | All components installed as per specifications. | Installation checklist signed by Engineering. |
| IQ-02 | Check flow rate and differential pressure. | Flow rate within specified limits; DP integrity maintained. | Flow rate and DP logs. |
| IQ-03 | Review audit trail of the control system. | Audit trail shows no unauthorized changes. | Audit trail report. |
Detailed Test Cases
Test Case: IQ-01
Objective: Verify that the installation of the Ophthalmic Sterile Filtration Skid meets manufacturer specifications.
Procedure: Review installation documentation and perform a walk-through of the installation site.
Acceptance Criteria: All components must be installed as per the manufacturer’s specifications.
Evidence: Completed installation checklist.
Test Case: IQ-02
Objective: Confirm that the flow rate and differential pressure are within acceptable limits.
Procedure: Conduct flow rate and DP tests using calibrated equipment.
Acceptance Criteria: Flow rate and DP must remain within defined limits.
Evidence: Test logs and reports.
Test Case: IQ-03
Objective: Ensure the integrity of the control system’s audit trail.
Procedure: Review the audit trail for any discrepancies.
Acceptance Criteria: No unauthorized changes should be present in the audit trail.
Evidence: Audit trail report.
Deviations
Any deviations from this protocol must be documented and justified. A deviation report must be submitted to Quality Assurance for review and approval.
Approvals
This protocol must be approved by the following personnel:
- Validation Team Lead: ______________________ Date: __________
- Quality Assurance Manager: ______________________ Date: __________
- Engineering Manager: ______________________ Date: __________
Data Integrity Checks
Data integrity checks relevant to this stage include:
- Verification of data logging functionality during operation.
- Regular audits of the control system’s data for accuracy.
- Validation of backup procedures for critical data.