The current guideline needs to be updated to reflect imminent changes 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 the consequent deletion of the monograph Water, highly purified. A new Ph. Eur. monograph “Water for preparation of extracts” (2249) is also published.
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 intention of the revision is to be in line with the revised Ph. Eur. monograph for Water for Injections (0169) and the consequent future deletion of the monograph Water, highly purified (1927).
The monograph (0169) revision is the result of extensive consultations with stakeholders.