Die sachkundige Person und der Umgang mit Testergebnissen außerhalb der Spezifikation
Dr. Uwe Amschler
Korrespondenz: Dr. Uwe Amschler, Ruschsehn 15 E, 24147 Klausdorf (Germany), e-mail: firstname.lastname@example.org
Qualified Person and Out-of-Specification (OOS) Test Results
A Qualified Person is responsible for securing in case of medicinal products, that each batch has been manufactured and checked in compliance with the laws in force and in accordance with the requirements of the marketing authorization. OOS results includes all test results that fall outside the specifications. In case of OOS results a medicinal product fails to meet established specifications and has to be rejected by the Qualified Person.
Key words Freigabe • Haftung • OOS-Ergebnisse • Qualified Person • Sachkundige Person
pharmind 2008, Nr. 12, Seite 1511