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The current guideline needs to be updated to Reflect imminent exchange in European Pharmacopoeia. The text of guideline needs to be updated to take into account manufacturing practices using methods --other than distillation for Producing water of injectable quality and therefore the deletion of the monograph Water, highly purified. A new Ph. Eur. monograph "Water for preparation of extracts" (2249) est aussi disponible.

The objective of the Guideline is to Provide Guidance to the Industry on the pharmaceutical use of different grades of water in the manufacture of active pharmaceutical ingredients and medicinal products for human and veterinary use.

The intent of the revision is to be revised in line with the Ph. Eur. monograph for Water for Injection (0169) and the future therefore deletion of the monograph Water, highly purified (1927).

The monograph (0169) revision is the result of extensive consultations with stakeholders.


Concept paper on the need for revision of Note for guidance on quality of water for pharmaceutical use (H + V)


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