Muenster (Germany), 26 June 2008. Audit service provider blue inspection body GmbH (www.blue-inspection.com) has appointed Prof. Dr. Werner Fresenius, for many years head of medicinal product surveillance in Rheinland-Pfalz, Germany, as chairman of its advisory board. Other members of the newly constituted board are Dr. Hans-Joachim Janhsen, Managing Director of CardioSec Clinical Research GmbH, and Dr. Eckhard Milsmann, Qualified Person at HAELSA Pharma GmbH. Together they advise the management of blue on all scientific and technical aspects of the worldwide auditing of active pharmaceutical ingredients. Working for the pharmaceutical industry, blue carries out accredited active pharmaceutical ingredient audits worldwide and checks good manufacturing practice (GMP) at supplier companies.
Active pharmaceutical ingredients and certain excipients have to meet the requirements of the EU-GMP guideline before they can be imported into Europe and used in medicinal products. Medicinal product manufacturers have to make regular on-site checks of compliance with those requirements at supplier companies in China or India, for example. The blue inspection body GmbH performs this task on their behalf. blue is the first inspection body for active pharmaceutical ingredients in the European Union to be accredited, at the beginning of June 2008, with the highest level of independence (ISO/IEC 17020, type A) by the DAP German Accreditation System for Testing.
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