Standard Operating Procedure for Water for Injection (WFI) Generation

1) Purpose

The purpose of this SOP is to outline the procedures for the generation of Water for Injection (WFI) to ensure its quality and compliance with regulatory standards for use in the manufacturing of injection products.

2) Scope

This SOP applies to all personnel involved in the generation and quality control of WFI at [Company Name] used for the manufacturing of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Production Department: Operating and maintaining WFI generation equipment.
– Quality Control (QC) Department: Testing WFI for compliance with quality standards.
– Quality Assurance (QA) Department: Reviewing and approving WFI quality data.

4) Procedure

4.1 Preparation for WFI Generation
4.1.1 Ensure all equipment is clean, sanitized, and in good working condition.
4.1.2 Verify that the water supply meets the required specifications for pre-treatment.
4.2 WFI Generation Process
4.2.1 Start the WFI generation system according to the manufacturer’s operating instructions.
4.2.2 Monitor the system parameters (temperature, pressure, conductivity) to ensure they remain within specified limits.
4.2.3 Collect WFI samples at designated intervals for quality testing.
4.3 Quality Control Testing
4.3.1 Conduct routine tests on WFI samples, including tests for conductivity, TOC (Total Organic Carbon), and microbial contamination.
4.3.2 Record test results and compare them with established acceptance criteria.
4.3.3 If WFI meets all quality specifications, it is approved for use. If not, investigate and take corrective actions.
4.4 System Maintenance
4.4.1 Perform regular maintenance on the WFI generation system as per the maintenance schedule.
4.4.2 Document all maintenance activities, including any repairs or replacements of parts.
4.5 Documentation
4.5.1 Maintain records of all operational parameters, test results, and maintenance activities.
4.5.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– WFI: Water for Injection
– QC: Quality Control
– QA: Quality Assurance
– TOC: Total Organic Carbon

6) Documents, if any

– WFI Generation System Operating Manual
– WFI Quality Control Test Records
– Maintenance Log

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
– Pharmacopeia Guidelines (e.g., USP, EP)

8) SOP Version

Version 1.0