The current guideline needs to be updated to reflect imminent changes in European Pharmacopoeia. The text of guideline needs to be made to account for the production of water for injection and the production of water for injection. 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 pharmaceutical industry on the use of pharmaceuticals in the manufacture of active pharmaceutical ingredients and medicinal products for human and veterinary use.
The intention of the revision is to be revised Ph. Eur. monograph for Water for Injections (0169) and the forthcoming deletion of the Water Monograph, highly purified (1927).
The monograph (0169) is the result of extensive consultations with stakeholders.