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