Guideline on the Quality of Water for Pharmaceutical Use

The document is intended to provide guidance to the industry on pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use.

The guidance compliments the “Questions and answers on production of water for injections by non-distilled methods – reverse osmosis and biofilms and control strategies EMA/INS/GMP/443117/2017 GMP/GDP Inspectors Working Group”

The guidance can be read in conjunction with the general principles sections 4&5 of Annex I, directive 2001/83/EC and the introduction and general principles section 2&3 of Annex I to directive 2001/82/EC

Draft Guideline Quality Water Pharmaceutical Use

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