Anforderungen an Wasser für Pharmazeutische Zwecke in USA und EuropaStand der internationalen Harmonisierung Klaus Haberer Compliance Advice and Services in Microbiology GmbH, Köln Requirements for Water for Pharmaceutical Purpose in the USA and Europe / State of international harmonisation Purified Water and Water for Injection (WFI) are the two main water qualities for the production of pharmaceuticals as described in the US and European pharmacopoeias. Within the past few years the compendial specification of these water qualities was modified first in USP and more recently in Ph. Eur. as well, to have separate requirements for water in bulk (water as distributed in pharmaceutical high purity water systems) and for bottled water. For water in bulk there is a tendency to formulate requirements for parameters which can be preferrably monitored online (total organic carbon (TOC) and conductivity, as well as microbiological alert and action levels) in order to characterise the state of control of the water system. On the other hand, for bottled water classical testing and release of the product based on acceptance limits is of primary importance. Unfortunately, in spite of all the efforts to achieve international harmonisation, the chance was missed by the pharmacopoeias to use the necessary restructuring of the water monographs to create internationally acceptable harmonised testing requirements. Also, the requirements for manufacturing of WFI are still not harmonised, mainly due to concern of the European authorities with regard to suitability of the pharmacopoeial microbiological testing method for water. Key words Gereinigtes Wasser · Internationale Harmonisierung · Wasser für Injektionszwecke |
|
|
pharmind 2000, Nr. 6, Seite 459
