26/27 September 2023
The WHO published the revised draft of its guideline "Good Manufacturing Practices: water for pharmaceutical use" already end of July. The first revised draft of the guideline was published in May 2020. The revision had become necessary due to the possibility of producing WFI in Europe also with non-distillative methods, such as membrane processes.
The now available second draft contains some changes compared to the previous version. The chapter on "Highly Purified Water (HPW)" is no longer included. This chapter was still included in the first draft, although the monograph from the European Pharmacopoeia has been dropped. The chapter on "Biocontamination control techniques" is also no longer included in the current draft, but the chapter on "System Sanitisation and bioburden control" is now more detailed. The chapter on "Bulk water for injections" has also grown considerably. There are more points in the list that should be considered for a robust WFI generation, e.g. for the sampling points, sanitisation strategy, alarms, electronic data recording and audit trail. In the chapter "Good practices for water systems", which includes design criteria for treatment and distribution, a distinction is now made between drinking water and purified water/WFI.
The new draft of the guideline "Good Manufacturing Practices: water for pharmaceutical use" (QAS/20.842/Rev1) can be found in the "Current Projects" section of the WHO website. The deadline for submission of comments is 11 September 2020.