WHO's Pharmaceutical Water Guideline to be revised

Recommendation

10-12 October 2023
Munich, Germany

Product Transfer
Organisation of a GMP-compliant Site Change

The WHO guideline "Good Manufacturing Practices: water for pharmaceutical use" is currently being revised. The WHO issued a draft for public comment in May 2020. The currently valid version of this guideline is dated 2011 and has been published as Annex 2 of the WHO Technical Report Series 970. The current revision of the WHO General Pharmaceutical Water Guideline is due to changes in the European Pharmacopoeia in 2017, from which date it was permitted for Europe to produce WFI using non-distillative methods.  

In this regard, the WHO has also recently adopted the guideline "Production of water for injection by means other than distillation". As a result, the monograph of "Water for Injection" will also be changed in the International Pharmacopeia of the WHO. Interestingly, the WHO Guide still contains a chapter (4.4) on "Highly Purified Water", i.e. a chapter on a water with the same quality attributes as WFI but which had not to be produced by destillation. For the production of WFI (4.5), alternatives to distillation are now mentioned in addition to distillation. Listed are: deionisation, nanofiltration, ultrafiltration, descaling, degassing or UV treatment in combination with single or double-pass reverse osmosis.

The draft of the guideline "Good Manufacturing Practices: water for pharmaceutical use" can be found in the "Current Projects" section of the WHO website. The deadline for comments is 30 June 2020.