GOOD MANUFACTURING PRACTICES: WATER FOR PHARMACEUTICAL USE

Overview

This document provides guidance on the production, storage, and distribution of water for pharmaceutical use (WPU) in bulk form. It outlines best practices for managing water quality, treatment systems, storage and distribution infrastructure, validation, testing, and routine monitoring.

Focusing on pharmaceutical applications, the document excludes water used in quality-control laboratories or for direct patient administration. It serves as a supplementary resource to WHO’s Good Manufacturing Practices (GMP) guidelines and includes references for further reading to support the planning and operation of WPU systems. By following these recommendations, manufacturers can align with regulatory expectations and uphold the integrity of water systems critical to pharmaceutical production.

Link to Document

TRS 1033 - ANNEX 3: GOOD MANUFACTURING PRACTICES: WATER FOR PHARMACEUTICAL USE