Document Control Number: IQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Installation Qualification Protocol for LVP/SVP Compounding Vessel
Objective: To ensure that the LVP/SVP Compounding Vessel operates according to specified requirements and is suitable for the preparation of bulk infusion solutions.
Scope: This protocol applies to the Installation Qualification of the LVP/SVP Compounding Vessel located in the Production area, intended for direct impact on product quality.
Responsibilities:
- Validation Team: Oversee the execution of the protocol and documentation.
- Production Staff: Assist in the execution of tests and provide necessary documentation.
- Quality Assurance: Review and approve the protocol and results.
Prerequisites:
- Completion of equipment installation.
- Training of personnel on equipment operation.
- Availability of necessary documentation (URS, SOPs).
Equipment Description: The LVP/SVP Compounding Vessel is a jacketed stainless steel vessel designed for the preparation of bulk infusion solutions. It is equipped with a PLC for monitoring critical parameters such as agitation, temperature, and hold time.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation of the vessel components. | All components installed as per manufacturer’s specifications. | Installation checklist signed off by the validation team. |
| IQ-02 | Perform PLC audit trail verification. | Audit trail shows no unauthorized changes. | Audit trail report from PLC system. |
| IQ-03 | Check agitation functionality. | Agitation operates within specified parameters. | Operational test log. |
| IQ-04 | Verify temperature hold time. | Temperature maintained as per specifications for required duration. | Temperature log records. |
Detailed Test Cases:
- Test Case IQ-01: Confirm installation of all vessel components against the manufacturer’s specifications.
- Test Case IQ-02: Review PLC audit trail for any unauthorized changes or anomalies.
- Test Case IQ-03: Operate the agitation function and confirm it meets the specified speed and consistency.
- Test Case IQ-04: Monitor and document the temperature during the hold time to ensure compliance with specifications.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.
Approvals:
- Validation Team Lead: ______________________ Date: ___________
- Quality Assurance: ______________________ Date: ___________
Data Integrity Checks:
- Ensure PLC systems are calibrated and validated prior to IQ execution.
- Confirm that all data logs are securely stored and backed up.
- Review access controls for PLC and data logging systems.