8/9 June 2021
The EDQM has announced the suppression of the Highly Purified Water (HPW) Monograph (1927) on 1 April 2019. This was justified with the revision of the European Pharmacopoeia which now allows non-distillation methods for the production of water for injection (WFI). As a consequence, the monograph became redundant. The EMA had only recently published their revised Q & A document on the topic of "cold WFI".
The Annex 1 Draft also contains new instructions on the production of WFI with membrane technology. The first document in particular suggests that additional and new measures will be required for the cold production of WFI. Among others, rapid microbiological methods are mentioned. It is quite surprising that the EDQM has now announced the suppression of the HPW monograph because - according to the EDQM - this was made redundant by the WFI monograph revision. This will mainly affect those companies that use HPW to clean production plants for example.
On the EDQM website you can find the announcement on the suppression of monograph 1927.