Good manufacturing practices: water for pharmaceutical use

Background:

Unlike other product or process ingredients, water is usually drawn from an on-demand system and is not subject to testing and batch or lot release prior to use. Thus it is essential that water quality (including microbiological and chemical quality) throughout production, storage and distribution processes is controlled.

In recent years, following extensive consultations with stakeholders, several pharmacopoeias have adopted revised monographs on water for injection (WFI) that allow for production by non-distillation technologies. In 2017, the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) recommended that the WHO Secretariat collect feedback on whether or not they should revise the WHO specifications and good manufacturing practices (GMP) on WFI and, if so, how to do so. Following several consultations, the ECSPP agreed that the monograph in The International Pharmacopoeia (Water for injections) and the guideline WHO Good manufacturing practices: water for pharmaceutical use (1), should both be revised to allow for technologies other than distillation for the production of WFI.

In early 2019, the WHO Secretariat commissioned a draft guidance text for the production of WFI by means other than distillation. Following several public consultations, the text was presented to the Fifty-fourth ECSPP. The Expert Committee adopted the Production of water for injection by means other than distillation guideline and recommended that it should also be integrated into WHO’s existing guideline on Good manufacturing practices: water for pharmaceutical use.

This document is a revision of WHO Good manufacturing practices: water for pharmaceutical use, previously published in the WHO Technical Report Series, No. 970, Annex 2, 2011.

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Table of Contents

1. Introduction and scope

2. Background to water requirements and uses

3. General principles for pharmaceutical water systems

4. Water quality specifications

4.1 Pharmacopoeial specifications

4.2 Drinking-water

4.3 Bulk purified water

4.4 Bulk water for injections

5. General considerations for water purification systems

6. Water storage and distribution systems