Die Rolle der Abteilung Qualitätssicherung im Umgang mit OOS-Resultaten
Dr. Olaf Kunze
CSL Behring, Marburg
Corresponding author: Dr. Olaf Kunze, CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041 Marburg (Germany), e-mail: email@example.com
Role of Quality Assurance Department in the Handling of OOS Test Results
An interpretation of the “FDA-Guidance for Industry: Investigating Out of Specification (OOS) Test Results” is presented and an FDA compliant procedure for investigating OOS results is proposed. Possible tasks for Quality Assurance are highlighted. In the author’s view an OOS investigation is divided into the three steps identification, investigation and assessment of an OOS. Quality Assurance will support the handling of OOS results in Quality Control laboratories by performing the typical QA tasks e. g. change control, investigation of deviations, SOP tracking and training. At the same time Quality Assurance will gain an overview over the OOS occurrences in QC laboratories. Furthermore QA may perform an OOS trending and will eventually implement corrective and preventive actions to avoid OOS results.
Key words Out of specification, limit, normal distribution, reportable value, retest
pharmind 2009, Nr. 6, Seite 1040