New EMA Guideline on use of pharmaceutical water
The guideline has been adapted based on the removal of the monograph for Highly Purified Water from the European Pharmacopoeia as well as changes in the European Pharmacopoeia including the revised monograph for Water for Injections allowing methods other than distillation for producing water of injectable quality. The new guideline will be coming into effect: Feb 1, 2021.
The new guideline contains 3 different pharmaceutical water qualities:
- Water for injection (revised monograph allows methods other than distillation for producing water of injectable quality)
- Purified water
- Water for the production of extracts (new since the draft of 2018).
The quality “potable water” is also mentioned which is – according to the EMA – not a pharmaceutical quality, but the required starting quality for the production of pharmaceutical water qualities.
The guideline has also been updated to reflect current expectations for the minimum acceptable quality of water used in the manufacture of active substances and medicinal products for human and veterinary use. The updated guideline will be effective from 1 February 2021.
LINK TO EMA COMMUNICATION AND GUIDELINE
Download the new guideline here: guideline-quality-water-pharmaceutical-use_en or directly at EMA
Keywords: Water, pharmaceutical use, grade, excipient, water for injections, purified water, distillation, reconstitution