WHO Good Manufacturing Practices: water for pharmaceutical use

April 6, 2012

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 the good m anufacturing practice (GMP) regarding the design, installation and
operation of pharmaceutical water systems.

Water is the most widely used substance, raw material or starting material in the production, processing and formulation of pharmaceutical
products. It has unique chemical properties due to its polarity and hydrogen bonds. This means it is able to dissolve, absorb, adsorb
or suspend many different compounds. These include contaminants that may represent hazards in themselves or that may be able to react
with intended product substances, resulting in hazards to health.

Different grades of water quality are required depending on the route of administration of the pharmaceutical products. One source of guidance about different grades of water is the European Medicines Evaluation Agency (EMEA) Note for guidance on quality of water for pharmaceutical use (CPMP/QWP/158/01).

Control of the quality of water throughout the production, storage and distribution processes, including microbiological and chemical quality, is a major concern.

Source: http://apps.who.int/prequal/info_general/documents/TRS929/WHO_TRS_929-Annex3.pdf