Regulatorische Anforderungen an die membranbasierte Herstellung von Wasser für Injektionszwecke (WFI)
GMP / GLP / GCP
Abstract
Regulatory Requirements for Membrane-Based Generation of WFI
With the modification of the monograph (0169) for Water for Injections (WFI) in April 2017 and the suppression of the Monograph (1927) for Highly Purified Water (HPW) in April 2019 in the European Pharmacopoeia, the regulatory framework for production of WFI has changed significantly. The use of reverse osmosis in combination with other membrane and ion exchange technologies for production of ultrapure water for drug production is now possible in many applications. There is a great deal of interest from pharmaceutical manufacturers in using the associated potential savings, although there is still great uncertainty regarding the regulatory framework and the approach of the control authorities. The quality of WFI and the requirements for generation of WFI are defined in a variety of regional laws, standards and guidelines. The WFI monograph and the Good Manufacturing Practice (GMP) guidelines of the country or the confederation in which the drug is sold are legally binding. Even though the international harmonization of regulatory requirements is steadily progressing, there are still very different regional specifications, especially regarding the membrane-based production of WFI. This paper gives an overview of the documents that are relevant to the membrane-based generation of WFI, briefly describes their content, and assesses their significance.
 | Jochen Schmidt-Nawrot ist seit mehr als 20 Jahren im Pharmawasserbereich tätig, u. a. bei Hager+Elsässer, BWT und Chemgineering. Aktuell ist er Process Utilities Lead beim Pharma und Biotech Engineering-Dienstleister CRB in Basel. Er beschäftigt sich schwerpunktmäßig mit der Konzeption, Verfahrensauswahl und Dimensionierung kompletter Wassersysteme zur Erzeugung, Lagerung und Verteilung von PW, WFI und Reindampf. Er ist langjähriges Mitglied der ISPE-DACH rCoP "Wasser & Dampf" und hat durch zahlreiche Präsentationen und Publikationen zum Thema WFI ohne Destillation die Zulassung von |
