WHO TRS (Technical Report Series) 970, 2012 Annex 2


WHO TRS (Technical Report Series) 970, 2012 Annex 2

WHO good manufacturing practices: water for pharmaceutical use

1. Introduction:

1.1 Scope of the document:

1.1.1 The guidance contained in this document is intended to provide information about the available specifications for water for pharmaceutical use (WPU), guidance about which quality of water to use for specific applications, such as the manufacture of active pharmaceutical ingredients (APIs) and dosage forms, and to provide guidance on good manufacturing practices (GMP) regarding the design, installation and operation of pharmaceutical water systems. Although the focus of this document is on water for pharmaceutical applications, the guidelines may also be relevant to other industrial or specific uses where the specifications and practices can be applied.

Note: This document does not cover water for administration to patients in the formulated state or the use of small quantities of water in pharmacies to compound individually prescribed medicines.

1.1.2 The GMP guidance for WPU contained in this document is intended to be supplementary to the general GMP guidelines for pharmaceutical products published by WHO (WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-seventh report. Geneva, World Health Organization, 2003 (WHO Technical Report Series, No. 908), Annex 4).

1.1.3 This document refers to available specifications, such as the pharmacopoeias and industry guidance for the use, production, storage and distribution of water in bulk form. In order to avoid confusion it does not attempt to duplicate such material.

1.1.4 The guidance provided in this document can be used in whole or in part as appropriate to the application under consideration.

1.1.5 Where subtle points of difference exist between pharmacopoeial specifications, the manufacturer will be expected to decide which option to choose in accordance with the related marketing authorization submitted to the national medicines regulatory authority.

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Table of contents

WHO TRS (Technical Report Series) 970, 2012 Annex 2:

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