EMA revises Guide on Pharmaceutical Water

Recommendation

2/3 March 2021

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According to the European Pharmacopoeia, it will be allowed as of the 1st of April 2017 to produce water for injection (WFI) using cold i.e. non-distillation methods (as already reported under "WFI obtained by non-distillation methods - What are the Next Steps?"). Now, the European Medicines Agency (EMA) has published a concept paper on the revision of the Note for Guidance on Quality of water for pharmaceutical use (CPMP/QWP/158/01 EMEA/CVMP/115/01). This Guideline from 2002 describes the different qualities of water for pharmaceutical use and their use in the production of medicinal products and/ or diverse dosage forms (e.g. topical, oral or parenteral). The paper also mentions the production of the different qualities and is in line with the present regulations of the European Pharmacopoeia which only allowed distillation for the production of WFI. The document also describes Highly Purified Water (HPW) and its use. HPW meets WFI quality but can be produced by means of membrane processes. Here, an essential aspect is the proposition of EMA's Quality Working Party  to remove in the future the monograph (1927) Highly Purified Water

On EMA's webpage you can find the "Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V)". Comments to this paper can be submitted until 6th June 2017.