EMA finalises Guideline on the Use of Pharmaceutical Water

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17-19 September 2024

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The European Medicines Agency (EMA) has published the final version of its guideline on the use of the different pharmaceutical water qualities. The revision had become necessary due to the possibility to produce WFI using methods other than distillation. The draft entitled "Guideline on the quality of water for pharmaceutical use" was published in 2018, and comments could be submitted until the middle of May 2019.

The "Guideline on the quality of water for pharmaceutical use" specifies which pharmaceutical water quality should be used for which pharmaceutical production process. It applies to the production of human and veterinary medicinal products as well as to the production of ATMPs (Advanced Therapy Medicinal Products).

As the monograph for Highly Purified Water, HPW (1927) from the European Pharmacopoeia has been removed, EMA's guideline also had to be adapted. The guideline now in force therefore contains three different pharmaceutical water qualities: WFI (water for injection), PW (purified water) and 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.

Except for modifications in the table for the minimum requirements for water quality in the production of active ingredients, the final version contains only few changes compared to the draft. For example, the exclusion of ATMPs in the manufacture of sterile ophthalmic products has been deleted, i.e. ATMPs are now also included here. WFI (formerly HPW was required) is now required for the final rinse in the cleaning of sterile equipment. A new exception is to be made for the production of sterile veterinary products, which allows the risk-based use of purified water for this step in special cases.

You will find the final version of EMA's "Guideline on the quality of water for pharmaceutical use" here.