1. U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center of Drug Evaluation and Research (CDER), Guidance for Industry, Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production, http://www.fda.gov/cder/guidance/3634fnl.pdf.
2. Out-of-specification issues (OOS)—Special Report, Institute of Validation Technology, http://www.ivtconferences.com/pdf/0906_oos.pdf.
3. R. Schmidt, FDA-/GMP-konforme Bearbeitung von OOS-Ergebnissen, Presentation in Course Nr. 405 der Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik (APV), http://www.apv-mainz.de.
4. J. Hartung, Statistik, Oldenbourg Verlag München, 8. Aufl. 1991.