Qualitätskultur und Qualitätskennzahlen
Fachthemen
Abstract
Quality Culture and Quality Metrics
Many companies desire to establish a culture of quality. Current pharmaceutical regulation tends to get more complicated and a patient and quality-centered view needs to come into focus. This article shows properties of a quality culture. Especially leadership and upper management of a company play an essential role in a quality culture. They need to emphasize the importance of quality and be a credible role model for all employees. Mutual support of personnel and an environment that enables continuous learning are also important enablers of a quality culture. Based on data of the pharmaceutical sector it could be shown that the maturity of such a culture can be measured by quality metrics. Such quality metrics are getting more and more employed in the pharmaceutical industry. Authorities want to utilize such indicators in order to improve supply of medicinal products. The U. S. Food and Drug Administration (FDA) published a draft guidance that is still in controversial discussion. It can be expected that manufacturers will be forced to disclose such quality metrics in future with authorities. Moreover, this article gives advice for definition and reporting of quality metrics to inform all levels of a company about the achievement of quality goals.
 | Dr. Jörg Schäffner promovierte nach dem Studium der Biochemie an der Universität Halle-Wittenberg auf dem Gebiet der Biotechnologie. Nach einer Tätigkeit im Projektmanagement war er ab 2005 am Aufbau der Good-Manufacturing-Practice(GMP)-Produktion der Scil Proteins Production GmbH beteiligt, leitete die Qualitätskontrolle, später auch die Qualitätssicherung und war als Sachkundige Person für die Freigabe von biologischen Wirkstoffen verantwortlich. Nach der Übernahme durch die Wacker Biotech GmbH leitete er die Qualitätssicherung der Standorte Halle und Jena. Seit Mai 2017 leitet er die |
