Zum Umgang mit Normabweichungen in der Laborpraxis Möglichkeiten der Umsetzung von GMP-Vorgaben bei sog. Out of Specification (OOS)-Testergebnissen Heribert Häusler a , Marcus Niehörster b und Klaus Peter Wörns a Boehringer Ingelheim Pharma KG a , Ingelheim, und Pharmaceutical Consultancy Services b , Neustadt Handling of Standard Deviations in Laboratory Practice / Ways to implement GMP requirements for so-called out-of-specification (OOS) test results A description is given of the implementation of FDA requirements with respect to handling OOS test results. By expanding the investigation stepwise from the actual test run to the manufacturing process, the investigation effort is reduced and adapted to suit the case in question. The use of check-lists and pre-printed forms helps systematise both the investigation itself and also documentation of the results (investigation report). Key words Normabweichungen · Out of Sepcification (OOS) · Ergebnisse · Qualitätskontrolle |