Standard Operating Procedure for WFI Storage and Distribution

1) Purpose

The purpose of this SOP is to outline the procedures for the storage and distribution of Water for Injection (WFI) to ensure its quality is maintained until use in the manufacturing of injection products.

2) Scope

This SOP applies to all personnel involved in the storage and distribution 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: Managing the storage and distribution of WFI.
– Quality Control (QC) Department: Testing WFI during storage and distribution.
– Quality Assurance (QA) Department: Reviewing and approving WFI quality data.

4) Procedure

4.1 Storage of WFI
4.1.1 Store WFI in stainless steel tanks that are sanitized and dedicated for WFI storage.
4.1.2 Ensure storage tanks are equipped with appropriate controls to maintain WFI quality (e.g., temperature control, microbial control).
4.1.3 Monitor and record storage conditions regularly.
4.2 Distribution of WFI
4.2.1 Distribute WFI through a dedicated, sanitized piping system to various points of use in the manufacturing facility.
4.2.2 Ensure all distribution lines are flushed and sanitized before use.
4.2.3 Monitor distribution system parameters (e.g., pressure, flow rate) to ensure consistent delivery.
4.3 Quality Control Testing
4.3.1 Conduct routine tests on WFI samples taken from storage tanks and distribution points.
4.3.2 Tests should include microbial testing, endotoxin levels, and conductivity.
4.3.3 Record and review test results to ensure WFI meets specified quality standards.
4.4 System Maintenance
4.4.1 Perform regular maintenance on WFI storage tanks and distribution systems 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 storage conditions, distribution 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

6) Documents, if any

– WFI Storage Tank Log
– Distribution System Monitoring Records
– 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