BAH committee visits Diapharm GmbH

11.11.2010 17:14

The pharmaceutical-technical committee of the Federal Association of Drug Manufacturers held its autumn meeting on November 3, 2010 in Münster.

The day before, the committee members met at Münster's Kreativkai at the invitation of Diapharm GmbH (www.diapharm.de) for lectures and discussions on the subject areas of “Accreditation & drug audits around the world” (Dr. Stefan Kettelhoit, blue inspection body GmbH ), “Transport validation for pharmaceuticals” (Dr. Franz-Josef Kappenberg, Diapharm GmbH) and “Benchmarking of quality costs” (Dr. Werner Zesch, Arthur D. Little GmbH and Dr. Frank Stieneker, APV).

This benchmarking project, which was launched by the Working Group for Pharmaceutical Process Engineering (APV), aims to determine the share of quality assurance in the manufacturing costs of pharmaceuticals. This is intended to provide pharmaceutical companies with a benchmark for the efficiency of their quality assurance measures. Another cost factor in drug production is the legal requirement to monitor the manufacturing process, even for purchased active ingredients. Here Dr. Stefan Kettelhoit from blue inspection body GmbH presents solutions that minimize the resulting audit effort for the individual pharmaceutical company.

The committee's fixed agenda items include the active exchange of experiences on inspections and audits as well as the creation of various guidelines and SOPs in the working groups. The BAH's pharmaceutical-technical committee includes a total of 25 members from pharmaceutical companies, including Dr. Sven Oliver Kruse is also a member of Diapharm.

November 11, 2010