WHO TRS (Technical Report Series) 1025, 2020 Annex 3

WHO TRS (Technical Report Series) 1025, 2020 Annex 3

Production of water for injection by means other than distillation

1. Introduction:

1.1 Water is widely used in the pharmaceutical industry. It is often used as a raw material; an ingredient in formulations; to prepare reagents; in cleaning; and in the manufacture of active pharmaceutical ingredients), intermediates and finished pharmaceutical products.

1.2 Water for pharmaceutical use must meet quality requirements and specifications, as published in relevant standards and pharmacopoeias. Water of the required quality for its intended use should be produced by appropriate methods.

2. Scope:

2.1 This document provides guidance for the production of water for injection (WFI) by means other than distillation. The principles described in this guideline may be applied to other grades of water, meeting other specifications.

2.2 The document is not exhaustive but aims to provide guidance on the main principles to be considered. Other guidelines and literature should also be consulted (1, 2).

3. Monographs:

3.1 Manufacturers should have appropriate specifications for WFI.

3.2 Monographs for WFI are published in The International Pharmacopoeia (1), as well as various national pharmacopoeias, and provide for the minimum requirements for the quality of WFI.

3.3 WFI should meet the specification as published in current monographs of the relevant pharmacopoeia recognized by the national medicines regulatory authority.

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WHO TRS (Technical Report Series) 1025, 2020 Annex 3:

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