DRINKING WATER

Drinking Water can be referred to as Potable Water (meaning drinkable or fit to drink), National Primary Drinking Water, Primary Drinking Water, or EPA Drinking Water. Except where a singular drinking water specification is stated (such as the U.S. EPA’s NPDWR, as cited in 40 CFR Part 141), this water must comply with the quality attributes of either the NPDWR or the drinking water regulations of the EU or Japan, or the WHO Guidelines for Drinking-Water Quality. Drinking Water may originate from a variety of sources including a public water supply, a private water supply (e.g., a well), or a combination of these sources

(see Source Water Considerations).

• Drinking Water may be used in the early stages of cleaning pharmaceutical manufacturing equipment and product-contact components.
• Drinking Water is also the minimum quality of water that should be used for the preparation of official substances and other bulk pharmaceutical ingredients. Where compatible with the processes, the contaminant levels allowed in Drinking Water are generally considered safe for use in preparing official substances and other drug substances.
• However, where required by the processing of the materials to achieve their required final purity, higher qualities of water may be needed for these manufacturing steps, perhaps even water as pure as Water for Injection or Purified Water.
• Such higher-purity waters, however, might require only selected attributes to be of higher purity than Drinking Water ( see Figure 1 and Figure 2 ).

• Drinking Water is the prescribed source or feed water for the production of bulk monographed pharmaceutical waters.
• The use of Drinking Water specifications establishes a reasonable set of maximum allowable levels of chemical and microbiological contaminants with which a water purification system will be challenged.
• Because seasonal variations in the quality attributes of the Drinking Water supply can occur, it is important to give due consideration to its uses.
• The processing steps in the production of pharmaceutical waters must be designed to accommodate this variability.