Dr Norbert Waldöfner appointed as managing director of Blue Inspection Body GmbH

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).

“The EXCiPACT procedure represents a sensible alternative and qualitative improvement to the purely client-specific audits carried out,” says Dr Norbert Waldöfner, lead auditor of blue inspection body.

Dr Norbert Waldoefner is the new managing director of Blue Inspection Body

blue inspection body GmbH becomes EXCiPACT certification body for pharmaceutical excipients

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 […]

EXCiPACT™-Certification Audits in North America conducted by mdc/blue

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 […]

blue inspection body reports on experiences with excipient audits

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 […]

2013 EU GMP Symposium

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 […]

Impurities in active pharmaceutical ingredients (APIs) targeted by EDQM

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.

Global alliance for Drug quality founded

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 […]

EXCiPACT scheme launched in the US at ExcipientFest Americas, Baltimore

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 […]

Manufacturers of Pharma-Excipients aiming for certified monitoring

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.

Blue Inspection Body audits Good Manufacturing Practice compliance of Biotec-derived Active Pharmaceutical Ingredient

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.