Vorbereitung einer Sterilproduktion auf eine behördliche InspektionGünter Bruckschlegel a , Christoph Eichele b und Alena Valasek c Chassot AG a , Belp/Bern (Schweiz), Vifor (International) AG b , St. Gallen (Schweiz), und Solco Basel AG c , Basel (Schweiz)
Preparation of a Sterile Production for Official Inspection An extensive remedy has been compiled for the preparation of a sterile production for an official inspection by the Intercantonal Office for the Control of Medicines (IKS) or the Regional Office for the Control of Medicines (RFS), based upon a fictitious company located in Switzerland and under regular control by the authorities. The partial aspect of preparation for inspection for the area of manufacture of a solution by degermination with subsequent aseptic filling into vials is given closer attention. The main emphasis lies in the planning, preparation and realisation of self-inspections, which should essentially be carried out in a âforward tracedâ manner. Key words Checklisten · Good Manufacturing Practice · Inspektion · Sterilproduktion |
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pharmind 1999, Nr. 12, Seite 1155
