| Anwendung der Risikoanalyse HACCP (Hazard Analysis and Critical Control Points) in der Produkteinführung und zur Festlegung eines Validierungsplanes Manfred Jantsch, Dr. Bettina Trotte, Birgit Schunke und Dr. Michael Jahnke Wülfing Pharma GmbH, Gronau Application of HACCP (Hazard Analysis and Critical Control Points) Risk Analysis for Product Introduction and Establishing Validation Activities Key words HACCP • Produkteinführung • Qualifizierung • Risikoanalyse • Technologietransfer Risk analysis following the HACCP Concept was applied for establishing validation activities required for the introduction of an aseptic process, the filling of sterile powder into glas vials. The processes for risk analysis were agreed upon within a multidisciplinary team following analysis of potential quality related risks focussing on the manufacuring process and the respective environment. A risk assessment table summarises and evaluates the risks and documents measures for minimising them. A corrective action plan (product specific validation plan) was established on the basis of uncontrolled risks. |
|
|
pharmind 2005, Nr. 4, Seite 471
