Münster (Germany), 01 February 2017. Dr Norbert Waldöfner is the new managing director of Blue Inspection Body GmbH (www.blue-inspection.com). Waldöfner has been lead auditor and quality management representative of the Blue Inspection Body GmbH since 2011. On behalf of pharmaceutical companies, Blue Inspection Body GmbH examines the Good Manufacturing Practices (GMP) of API manufacturers worldwide. Dr Norbert Waldöfner is a Chemist with a doctorate degree and an interdisciplinary mindset. He studied at Duisburg University and passed his doctorate degree at the Max-Planck-Institute Muelheim (Germany) and the RWTH Aachen (Germany).
Münster (Germany), 28 April 2016. blue inspection body GmbH (www.blue-inspection.com) is registered by EXCiPACT as a certification body for excipients used in the production of pharmaceuticals. This is conditional upon accreditation according to DIN EN ISO/IEC 17021, which blue received in December 2015. The EXCiPACT industry initiative provides a certification scheme for the independent monitoring […]
Consortium monitors the quality of excipients for medicinal products New York (USA), Stuttgart (DE), Münster (DE), 15 September 2014. After the successful start in Europe, mdc medical device certification GmbH (mdc) now offers in cooperation with blue inspection body GmbH (blue) EXCiPACTTM audits for excipient manufacturers and distributors based in the USA and Canada. For […]
EXCiPACT auditors are guests at CPhI China and ExcipientFest Shanghai (CN), Amsterdam (NL), Münster (DE), 15 July 2014 – The industry initiative EXCiPACT was launched a year ago to improve monitoring of pharmaceutical excipients. At the CPhI China in Shanghai and the ExcipientFest Europe in Amsterdam, the auditors of blue inspection body (www.blue-inspection.com) have now […]
Bejing (China), Muenster (Germany), 25. September 2013 – During the 2013 EU GMP Symposium in Beijng, China, Dr. Stefan Kettelhoit (blue inspection body GmbH) provided Chinese pharmaceutical manufacturers with fresh insights into European cGMP regulations and into the concepts and processes of on-site inspections by European authorities. The lead auditor of blue inspection body GmbH […]
Shanghai, Beijing (China), Muenster (Germany), 15 July 2013 – More than 100 participants from industry, authorities and inspection bodies discussed suitable measures to adequately control impurity levels in APIs during the “EU CEP Symposium 2013” in Shanghai.
Chinese Chamber of Commerce for Import & Export of Medicines & Health Products signs co-operation contract with 3rd party GMP auditor blue inspection body Beijing (China), Muenster (Germany), 11 June 2013 – Effective 01 June 2013, the China Chamber of Commerce for Import & Export of Medicines & Health Products (www.cccmhpie.org.cn) and the German Good […]
Aiming for tighter surveillance of excipients used in medicines Baltimore (USA), Münster (DE), 06 May 2013. The EXCiPACT certification scheme, an initiative of industrial associations from excipient and pharma suppliers, has officially been launched in the US. EXCiPACT is aiming for an independent and impartial monitoring of Good Manufacturing Practice (GMP) and Good Distribution Practice […]
The first Certification Body for ‚Excipients’ starts to work Muenster, 28 November 2012. Supported by extensive professional knowledge of blue inspection body GmbH, the mdc medical device certification GmbH represents the first European Certification Body for pharmaceutical excipients. mdc and EXCiPACT have signed a respective framework agreement.
Muenster (Germany), 16 March 2012. The first accredited Good Manufacturing Practice (GMP) inspection body in Europe broadens its range of services: blue inspection body (www.blue-inspection.com) successfully completed an audit of an antibody manufacturing site for a Russian pharmaceutical company.