EMA revises Guide on Pharmaceutical Water
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 (Click Here for Download) 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.
The (Click here) "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.
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