Document Control
Document Number: IQ-OCV-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Installation Qualification Protocol for Ophthalmic Compounding Vessel
Objective: To ensure the installation of the Ophthalmic Compounding Vessel is compliant with defined specifications and operational requirements.
Scope: This protocol applies to the installation qualification of the Ophthalmic Compounding Vessel in the production area for the preparation of ophthalmic bulk solution and ointment base.
Responsibilities:
- Validation Team: Conduct and document the qualification activities.
- Production Team: Provide access to the equipment and assist during installation.
- Quality Assurance: Review and approve the protocol and results.
Prerequisites:
- Completion of equipment delivery and setup.
- Availability of installation manuals and operational procedures.
- Training of personnel on equipment operation and maintenance.
Equipment Description:
The Ophthalmic Compounding Vessel is a jacketed stainless steel vessel designed for the preparation of sterile eye drops and ointments. It features controlled agitation, temperature monitoring, and holds critical parameters for the production process.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify equipment installation according to manufacturer’s specifications. | Installation meets all specified requirements. | Installation checklist signed by validation team. |
| IQ-02 | Check PLC audit trail functionality. | Audit trail is complete and accessible. | PLC report showing audit trail logs. |
| IQ-03 | Validate agitation settings and temperature hold time. | Agitation and temperature hold time meet defined specifications. | Data logs from the equipment. |
Detailed Test Cases:
Test Case IQ-01
Objective: Verify that the equipment is installed correctly.
Procedure: Inspect the equipment installation against the manufacturer’s specifications.
Acceptance Criteria: All installation points must comply with specifications.
Evidence: Signed installation checklist.
Test Case IQ-02
Objective: Ensure the PLC audit trail is functioning.
Procedure: Access the PLC system and review the audit trail logs for completeness.
Acceptance Criteria: Audit trail must show no gaps or missing data.
Evidence: PLC audit trail report.
Test Case IQ-03
Objective: Validate the agitation and temperature hold parameters.
Procedure: Run the vessel through a cycle and record the agitation and temperature hold times.
Acceptance Criteria: Parameters must be within specified limits.
Evidence: Data logs from the equipment.
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:
Conduct regular audits of the PLC data logs to ensure data integrity and compliance with regulatory requirements.