Regelwerke zur Herstellung von Pharmawasser und Behördeninspektion von WassersystemenKlaus Feuerhelm Leitstelle Arzneimittelüberwachung Baden-Württemberg, Tübingen Regulatory Guides for the Production of Pharmaceutical water and Official Inspection of Water Production and Process Plants Water is the most important raw material in drug production. Of particular importance is the fact that even during the production process, the quality of the water has to be continuously monitored. In that, the pharmaceutical process water plays an exceptional role among the basic materials. The water is usually used continuously directly after it has been processed, whereas the other basic materials undergo the familiar clearance procedure. The inspection of the water processing plants plays a significant role in the control of drug manufacturers. Legal guidelines for the quality of pharmaceutical process water and the plants with which the water is produced, distributed and stored, result from the European Pharmacopoeia, the Pharmabetriebsverordnung (PharmBetrV) and the EG-GMP-Guideline including the appendages. The present article illustrates the most important contents of the mentioned regulatory guides on the subject of pharmaceutical water. It should also deliver insight on the inspection of water production and process plants by the regulatory authorities. The aim of this article is to address the particular priorities of the regulatory inspection from the point of view of an inspector. Key Words EG-GMP-Leitfaden · Inspektion · Wasser für Injektionszwecke · Wassersystem |
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pharmind 2003, Nr. 3, Seite 276
