Pharmaceutical Water Guideline (WHO)

An update from the European Compliance Academy on the revised WHO standard for pharmaceutical water.

The current TRS 970 of the WHO comprises an updated version of the guideline regarding the manufacture and distribution of water for pharmaceutical use. The range of the guideline's scope has been narrowed by excluding the processing small amounts of water in pharmacies. A key change is the indication that the design of a water system is important for avoiding microbiological growth in the system (in the previous version only the sanitisation was mentioned as control measure). The authors also emphasise the importance of the appropriate capacity to ensure a sufficient re-circulation.

A further change is that the pharmaceutical manufacturer must be responsible for ensuring that the feed water has drinking water quality. If the in-coming water is not of a suitable quality, the manufacturer must take suitable measures in a step prior to the actual treatment to guarantee this quality.

With regard to purified water (AP) the revision now mentions the possible treatment components (reverse osmosis and EDI). The amendment states (similar to the USP) that warning limits are supposed to be based on operational experience.

To view the revised standard, go to: ECA

Posted by Tim Sandle