Installation Qualification Protocol for Water System (PW/WFI) for IV Infusions
Document Number: IQ-001
Version: 1.0
Effective Date: [Insert Date]
Approval: [Insert Names and Titles]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Water System (PW/WFI) for Point of Use in LVP/SVP applications is installed according to specifications and is capable of delivering water that meets the required quality standards for compounding and cleaning in place (CIP) processes.
Scope
This protocol applies to the Water System (PW/WFI) installed in the Utilities area, specifically designed for direct use in IV Infusions. It covers the verification of critical parameters to ensure compliance with relevant guidelines.
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Maintenance Team: Responsible for ensuring the system is operational and maintained as per standards.
Prerequisites
- Completion of Equipment Installation.
- Availability of relevant documentation including User Requirement Specification (URS).
- Training of personnel involved in the validation process.
Equipment Description
The Water System (PW/WFI) is designed for Point of Use applications to provide purified water for compounding and CIP. It is critical for ensuring the quality of water used in IV Infusions.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation against the approved design specifications. | All components are installed as per design specifications. | Installation checklist signed by validation team. |
| IQ-02 | Conduct conductivity testing. | Conductivity < 1.3 µS/cm. | Conductivity test results log. |
| IQ-03 | Perform TOC testing. | TOC < 500 ppb. | TOC test results log. |
| IQ-04 | Microbial testing. | No microbial growth detected. | Microbial test results log. |
| IQ-05 | Temperature audit trail verification. | Temperature maintained within specified limits. | Audit trail report. |
Detailed Test Cases
Test Case: IQ-01
Procedure: Verify installation against the approved design specifications.
Acceptance Criteria: All components are installed as per design specifications.
Evidence: Installation checklist signed by validation team.
Test Case: IQ-02
Procedure: Conduct conductivity testing.
Acceptance Criteria: Conductivity < 1.3 µS/cm.
Evidence: Conductivity test results log.
Test Case: IQ-03
Procedure: Perform TOC testing.
Acceptance Criteria: TOC < 500 ppb.
Evidence: TOC test results log.
Test Case: IQ-04
Procedure: Microbial testing.
Acceptance Criteria: No microbial growth detected.
Evidence: Microbial test results log.
Test Case: IQ-05
Procedure: Temperature audit trail verification.
Acceptance Criteria: Temperature maintained within specified limits.
Evidence: Audit trail report.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be developed as necessary.
Approvals
This protocol must be reviewed and approved by the Quality Assurance team prior to execution. All results must be documented and approved upon completion of the validation activities.