Qualitäts- und Umweltmanagement in einem forschenden Pharmaunternehmen
Dr. Annett-Kathrin Gyraa, Eckhard Freitaga und Dr. Günter Brendelbergerb
Jenapharm GmbH & Co. KGa, Jena, und Concept Heidelbergb, Heidelberg
This article describes the introduction of a company-wide quality and environmental management system (QMS/EMS) in a pharmaceutical company engaged in research. The aim of this project was the documented implementation of the national and international GMP requirements with simultaneous certification of the QMS and EMS. The start, the implementation and the progress of the project are described in detail, especially the structures of the manual and of the system documentation.
The project was concluded in June 2002 with the certification of the company according to the new DIN ISO 9001 : 2000 and DIN ISO 14001.
pharmind 2003, Nr. 11, Seite 1102