Operational Qualification Protocol for WFI Generation System
Document Number: OQ-WFI-001
Version: 1.0
Effective Date: YYYY-MM-DD
Review Date: YYYY-MM-DD
Prepared By: [Name]
Approved By: [Name]
Objective: To ensure the Water for Injection (WFI) Generation System operates within specified limits and meets the requirements outlined in the User Requirement Specification (URS) and regulatory guidelines, specifically Annex 11 and Annex 15.
Scope: This protocol covers the Operational Qualification of the WFI Generation System used for the production of Water for Injection, which is critical for direct product impact.
Responsibilities:
- Validation Team: Conduct and document the OQ tests.
- Quality Assurance: Review and approve the OQ protocol and results.
- Engineering: Ensure the system is set up and functioning properly prior to testing.
Prerequisites:
- Completion of Installation Qualification (IQ).
- System is fully operational and calibrated.
- All relevant documentation is available for review.
Equipment Description: The Water for Injection Generation System is designed to produce WFI in compliance with pharmacopoeial standards, featuring critical parameters such as conductivity, total organic carbon (TOC), microbial limits, temperature, and audit trails for data integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Conductivity Measurement | Conductivity < 1.3 µS/cm | Calibration report and test log |
| OQ-02 | TOC Analysis | TOC < 500 ppb | TOC test report |
| OQ-03 | Microbial Testing | No growth in 100 mL sample | Microbial test report |
| OQ-04 | Temperature Verification | Temperature maintained at 20-25°C | Temperature log |
| OQ-05 | Audit Trail Review | All actions recorded and retrievable | Audit trail report |
Detailed Test Cases
Test Case OQ-01: Conductivity Measurement
Procedure: Measure the conductivity of the WFI using a calibrated conductivity meter. Record the results.
Acceptance Criteria: Conductivity must be less than 1.3 µS/cm.
Evidence: Document the results in the test log and attach the calibration report.
Test Case OQ-02: TOC Analysis
Procedure: Perform TOC analysis on a sample of WFI using an approved method.
Acceptance Criteria: TOC must be less than 500 ppb.
Evidence: Attach the TOC test report to the protocol.
Test Case OQ-03: Microbial Testing
Procedure: Conduct microbial testing on a 100 mL sample of WFI.
Acceptance Criteria: No growth in the sample.
Evidence: Include the microbial test report.
Test Case OQ-04: Temperature Verification
Procedure: Verify the temperature of the WFI storage system.
Acceptance Criteria: Temperature must be maintained between 20-25°C.
Evidence: Record temperature logs during testing.
Test Case OQ-05: Audit Trail Review
Procedure: Review the audit trail for the WFI system to ensure all actions are logged.
Acceptance Criteria: All actions must be recorded and retrievable.
Evidence: Provide the audit trail report.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A corrective action plan should be established and approved by Quality Assurance.
Approvals
Prepared By: ____________________ Date: __________
Approved By: ____________________ Date: __________
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