Fritz Röder (Merck KGaA)
Jochen Schmidt-Nawrot (CRB Group GmbH)
In Europe it has become possible to produce water for injection (WFI) using non-distillation methods since March 2017. The change in the European Pharmacopoeia allows WFI production by means of suitable methods such as reverse osmosis. However, the EU Commission has also pointed out that in order to ensure the quality of a “cold-produced” WFI, other measures have to be taken than those required previously for the mandatory distillation.
The robustness of this new process has to be demonstrated. The Q&A document prepared for this purpose by the EMA provides further assistance in some areas, but also leaves many questions unanswered. In addition, the monograph on Highly Purified Water (HPW) will be suppressed as of April 2019. Now, the most obvious question is: how will HPW - after its suppression from the European Pharmacopoeia - become Water for Injection (WFI)?
The target group of this Webinar are specialists from pharmaceutical companies (production, qualification, quality assurance) as well as from planning and plant engineering who are entrusted with the construction, operation or maintenance of WFI producing equipment.
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you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The Webinar on 25 June will address and answer the following questions:
- What is the current regulatory status? What do Pharmaceutical
- Associations say?
- Which technologies are appropriate for the cold production of WFI?
- Where do the new risks lie?
- What are the measures to counter those risks?
- What does happen to existing HPW systems?
- How to set up a suitable control strategy?
- What is the feedback from pharmaceutical “cold WFI” projects?
Recording from 25.06.2019
Duration of recording: 1,5 h.