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The latest press releases about third party audits for the pharma sector are available for you on these pages. Publication for editorial and scientific purposes is free of charge; please send us brief notification or a specimen copy.

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  • 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 ( 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

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  • blue inspection body GmbH becomes EXCiPACT certification body for pharmaceutical excipients 28. April 2016

    Münster (Germany), 28 April 2016. blue inspection body GmbH ( 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 of good manufacturing practices (GMP) and good distribution practices (GDP) of excipients. blue inspection body was accredited as the first provider of GMP audits for active pharmaceutical ingredients in Europe according to DIN EN ISO 17020 as early as 2008. Since 2012, blue inspection has also conducted GMP audits for pharmaceutical excipients.

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    • EXCiPACT™-Certification Audits in North America conducted by mdc/blue 15. September 2014

      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 these EXCiPACT™ audits, mdc/blue plan coordinated audit tours in North America, which will be conducted concurrently for several suppliers during one trip. Wolfgang Tessmer, Managing Director of the audit service provider blue ( explains: “Due to the bundling of several audits within one trip, the applicable travelling costs will be significantly reduced for each audited company”.

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    • blue inspection body reports on experiences with excipient audits 15. July 2014

      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 ( have now drawn an initial conclusion: “Overall, the level of awareness for Good Manufacturing and Good Distribution Practices at excipient manufacturers has increased significantly in the past twelve months,” declared lead auditor Dr. Norbert Waldöfner in a presentation at the IPEC China Excipient Regulatory and Quality Control Seminar during the CPhI in Shanghai. “This is certainly partly due to the fact that the regulatory authorities have placed a stronger focus on the topic.” Shortly before, one of blue’s shareholders, Dr. Stefan Kettelhoit had already informed the participants at the ExcipientFest congress Europe in Amsterdam about the experiences with the first EXCiPACT audits.

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    • 2013 EU GMP Symposium 24. October 2013

      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 gave, amongst others, a talk on the EU GMP Guide Part I & II.

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    • Impurities in active pharmaceutical ingredients (APIs) targeted by EDQM 15. July 2013

      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.

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    • Global alliance for Drug quality founded 11. June 2013

      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 ( and the German Good Manufacturing Practices (GMP) 3rd party auditor blue inspection body GmbH ( form a strategic co-operation. Its primary goal is to support Chinese manufacturers of drug products and active ingredients (APIs) in the framework of their quality management system (QMS) to comply with European GMP regulations.

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    • EXCiPACT scheme launched in the US at ExcipientFest Americas, Baltimore 6. May 2013

      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 (GDP) compliance.

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    • Danish Medicines Agency develops guideline for API audits 15. July 2010

      Muenster (DE), Copenhagen (DK), 19. Juli 2010. The Danish Medicines Agency DMA intends to develop an own guideline for API audit reports, which shall provide guidance to finished medicinal product manufacturers for the documentation of the GMP compliance of their active pharmaceutical ingredient (API) suppliers. This is the result of a survey conducted by the DMW last year concerning the GMP surveillance of pharmaceutical companies .

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    • Dr Kerstin Tabatt joins the team of blue inspection body GmbH as GMP auditor 20. April 2010

      Muenster (Germany), 20 April 2010. Dr Kerstin Tabatt extends the current team of ten GMP auditors at blue inspection body GmbH ( effective 1 May 2010. Dr Tabatt has a professional background as a pharmacist and holds a doctorate in pharmaceutical technology. Prior, she worked as a Qualified Person at PenCef Pharma GmbH in Berlin, where supplier audits were part of her responsibilities.

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    • blue inspection body celebrates 50 GMP audits 20. November 2009

      Muenster (Germany), 20 November 2009. Two years after founding the company and just 18 months after gaining the accreditation blue inspection body GmbH announced today the successful execution of its 50th GMP audit. Further audit trips to China, India, Israel and various European countries have been scheduled already, meaning that in the first quarter 2010 the 75th audit is targeted to be completed.

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    • Woerwag treads unconventional paths in quality assurance 30. April 2009

      Boeblingen, Muenster (Germany), 30 April 2009. Woerwag R&D, specialised in the development of medicinal products, has for the first time sought certification of good manufacturing practices (GMP) for two new generics by an external accredited auditor. The blue inspection body GmbH ( served as an independent third-party auditor for the GMP compliant manufacturing of Clopidogrel and Losartan. The company is the first accredited, commercially organized inspection body for active pharmaceutical ingredients (APIs) in Europe.

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    • EDQM suspends Certificates of Suitability for Chinese APIs 22. April 2009

      Muenster (Germany), 22. April 2009. On April 14th, 2009 the European Directorate for the Quality of Medicines & HealthCare (EDQM) has suspended the Certificates of Suitability of four active pharmaceutical ingredients (APIs) manufactured in China. Two Benzylpenicillin products (R0-CEP 2004-001-Rev 00, R0-CEP 2004-017-Rev 00) of the company Hebei Huari Pharmaceuticals Ltd. as well as Dihydrostreptomycin sulphate (R1-CEP 2000-069-Rev 00) and Neomycin sulphate (R0-CEP 2001-317-Rev 02) of Sichuan Long March Pharmaceutical Co. Ltd are affected.

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    • blue inspection body audits active pharmaceutical ingredient manufacturers in China und India 13. February 2009

      Muenster (Germany), 13 February 2009. The audit service provider blue inspection body GmbH ( will be conducting third-party audits of excipient and active pharmaceutical ingredient (API) manufacturers in Asia at the beginning of March.

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