Document Control Number: IQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approved By: [Name]
Installation Qualification Protocol for Liquid Manufacturing Vessel
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Liquid Manufacturing Vessel (SS Jacketed Tank) is installed correctly and operates according to the specified requirements, ensuring the quality and safety of compounded syrups and liquids.
Scope
This protocol applies to the Installation Qualification of the Liquid Manufacturing Vessel used in the production area for compounding non-sterile liquids, specifically oral liquids, syrups, and suspensions.
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
- Maintenance Team: Responsible for ensuring the equipment is installed and maintained according to manufacturer specifications.
Prerequisites
- Completion of the equipment installation.
- Availability of necessary documentation including URS and equipment manuals.
- Training of personnel on the operation of the equipment.
Equipment Description
The Liquid Manufacturing Vessel is a stainless steel jacketed tank designed for the compounding of non-sterile liquids such as syrups and suspensions. It features controls for agitation speed, temperature, and hold time, and is equipped with a PLC for logging operational parameters.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-001 | Verify installation against the manufacturer’s specifications. | All components installed as per specifications. | Installation checklist signed off. |
| IQ-002 | Check PLC logs for initial setup. | PLC logs show correct configuration. | PLC log printouts. |
| IQ-003 | Test agitation speed settings. | Agitation speed within specified range. | Calibration report. |
| IQ-004 | Verify temperature control functionality. | Temperature maintained within specified limits. | Temperature log records. |
| IQ-005 | Confirm hold time accuracy. | Hold time meets specified requirements. | Operational logs. |
Detailed Test Cases
Test Case: IQ-001
Procedure: Verify installation against the manufacturer’s specifications.
Acceptance Criteria: All components installed as per specifications.
Evidence: Installation checklist signed off by the validation team.
Test Case: IQ-002
Procedure: Check PLC logs for initial setup.
Acceptance Criteria: PLC logs show correct configuration.
Evidence: Printouts of PLC logs confirming setup.
Test Case: IQ-003
Procedure: Test agitation speed settings.
Acceptance Criteria: Agitation speed within specified range.
Evidence: Calibration report confirming speed settings.
Test Case: IQ-004
Procedure: Verify temperature control functionality.
Acceptance Criteria: Temperature maintained within specified limits.
Evidence: Temperature log records during operation.
Test Case: IQ-005
Procedure: Confirm hold time accuracy.
Acceptance Criteria: Hold time meets specified requirements.
Evidence: Operational logs demonstrating hold time.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A deviation report should be generated and reviewed accordingly.
Approvals
This protocol must be reviewed and approved by the Quality Assurance team prior to execution. Signatures below indicate approval:
____________________ (Quality Assurance) Date: ___________
____________________ (Validation Team Lead) Date: ___________