Feed water requirements for Stills and GVP

GOOD VALIDATION PRACTICE (cGVP) PURIFIED WATER VALIDATION
1

Hi everyone,

I would like to know if there is a regulatory requirement for the quality of the feed water to produce WFI or Clean Steam ? Is it a regulatory requirement to use PW or just a recommendation ?

In fact, it seem that is the supplier’s requirements which recommand a such quality but is it regulatory ?
If it is, could you please tell me in which pharmacopiae or anything else it is written ?

Thanks a lot

2

According to USP General Chapter <1231>, ‘water for pharmaceutical purpose’, “The minimum quality of source or feed water for the generation of Water for Injection is Drinking Water as defined by the U.S. EPA, EU, Japan, or the WHO. This source water may be pre-treated to render it suitable for subsequent distillation”.So, better you should use purified water.