Standard Operating Procedure for Water for Injection (WFI) Generation

1) Purpose

The purpose of this SOP is to establish procedures for the generation of Water for Injection (WFI) to ensure it meets quality standards for use in the manufacturing process.

2) Scope

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

3) Responsibilities

The responsibilities of this SOP include:
– Engineering Department: Operating and maintaining WFI generation equipment.
– Quality Assurance (QA) Department: Monitoring and approving WFI quality.

4) Procedure

4.1 Preparation for WFI Generation
4.1.1 Ensure the WFI generation system is clean and free from contaminants.
4.1.2 Verify that all system components are functioning properly.
4.2 WFI Generation Process
4.2.1 Start the WFI generation system according to the manufacturer’s instructions.
4.2.2 Monitor the system parameters such as temperature, pressure, and flow rate during operation.
4.2.3 Collect samples at specified intervals to test for quality parameters such as endotoxins, conductivity, and microbial contamination.
4.3 Quality Control and Monitoring
4.3.1 Conduct regular tests on WFI samples to ensure compliance with quality standards.
4.3.2 Record all test results and monitor trends over time to detect any deviations or issues.
4.4 Maintenance and Calibration
4.4.1 Perform regular maintenance on the WFI generation system as per the manufacturer’s guidelines.
4.4.2 Calibrate all measurement instruments regularly to ensure accuracy.
4.5 Documentation
4.5.1 Maintain records of all operations, tests, maintenance, and calibrations related to WFI generation.
4.5.2 Ensure all documentation is signed and dated by the responsible personnel.

5) Abbreviations, if any

– QA: Quality Assurance
– WFI: Water for Injection

6) Documents, if any

– WFI Generation Logs
– Quality Control Test Records
– Maintenance and Calibration Logs

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards

8) SOP Version

Version 1.0