Operational Qualification Protocol for Water System (PW/WFI) for IV Infusions
Document Control Number: OQ-WS-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Water System (PW/WFI) operates within defined parameters to ensure the quality and safety of water used in the compounding of IV infusions.
Scope
This protocol applies to the Water System (PW/WFI) used as a Point of Use system for LVP and SVP in the Utilities area. It covers all aspects of the system impacting the quality of water for compounding and cleaning-in-place (CIP) processes.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Operations: Responsible for maintaining the equipment and ensuring it is ready for testing.
Prerequisites
- Completion of Installation Qualification (IQ).
- All relevant personnel trained on the Water System operation.
- Calibration of all measurement instruments used in testing.
Equipment Description
The Water System (PW/WFI) is designed to provide purified water for compounding IV infusions. It includes components for filtration, storage, and point-of-use delivery. Key parameters include conductivity, total organic carbon (TOC), microbial limits, and temperature control.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Conductivity Measurement | Conductivity < 1.3 µS/cm | Conductivity log |
| OQ-02 | TOC Measurement | TOC < 500 ppb | TOC log |
| OQ-03 | Microbial Testing | No growth in 100 mL sample | Microbial test results |
| OQ-04 | Temperature Audit Trail | Temperature within 20-25°C | Temperature log |
Detailed Test Cases
Test Case OQ-01: Conductivity Measurement
Procedure: Measure the conductivity of the water at the point of use using a calibrated conductivity meter. Record the value.
Acceptance Criteria: The conductivity must be less than 1.3 µS/cm. If the reading exceeds this limit, corrective action must be taken.
Evidence: Conductivity log must be attached to the final report.
Test Case OQ-02: TOC Measurement
Procedure: Collect a water sample and analyze for total organic carbon using a TOC analyzer.
Acceptance Criteria: The TOC must be less than 500 ppb. If the TOC exceeds this limit, an investigation must be initiated.
Evidence: TOC analysis report must be attached to the final report.
Test Case OQ-03: Microbial Testing
Procedure: Perform a microbial test by collecting a 100 mL sample of water and incubating it for 48 hours.
Acceptance Criteria: No microbial growth should be observed. If growth is detected, a thorough investigation is required.
Evidence: Microbial test results must be attached to the final report.
Test Case OQ-04: Temperature Audit Trail
Procedure: Review the temperature audit trail logs to ensure that the temperature remained within the specified range during water storage and delivery.
Acceptance Criteria: Temperature should remain between 20-25°C. Any deviations must be documented and investigated.
Evidence: Audit trail logs must be attached to the final report.
Deviations
Any deviations from the acceptance criteria must be documented in a deviation report. The report should include the nature of the deviation, investigation results, and corrective actions taken.
Approvals
Prepared by: [Name, Title]
Reviewed by: [Name, Title]
Approved by: [Name, Title]