Answer:

The Ph. Eur. General Notices (section 1.1.1.2 Conventional terms) state that “if criteria for suitability are not described in the text, suitability is demonstrated to the satisfaction of the competent authority”. Due to the borderline nature of dialysis solutions (medicinal product or medical device), it is acknowledged that the quality requirement of the water used to dilute concentrated solutions is defined differently depending on the country, with some countries opting for the quality standards required for medical devices and others for the Ph. Eur. quality standards for medicines. Ultimately, the quality of the final HF/HDF solutions must comply with the requirements prescribed in monograph 0861, regardless of whether they are ready-to-use bags or prepared on-line by diluting the HF/HDF concentrates with water. In the case of on-line preparations, this must be achieved using validated and approved medical devices.