Muenster (Germany), 20 April 2010. Dr Kerstin Tabatt extends the current team of ten GMP auditors at blue inspection body GmbH (www.blue-inspection.com) 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. Blue inspection body GmbH globally examines the Good Manufacturing Practice (GMP) compliant manufacturing of APIs and medicinal products on behalf of pharmaceutical companies. It is the first accredited Type-A inspection body for this purpose in the European Union.
The manufacturing of starting materials and active pharmaceutical ingredients for medicinal products is primarily conducted outside Europe: It is estimated by the European Medicines Agency EMA that more than 80 percent of the starting materials and APIs used for manufacturing finished medicinal products in Europe and the USA are sourced from third countries outside the European Economic Area (EEA) or the USA. Major supplier countries are India and China. Third-party audits, conducted globally by blue, are used by the pharmaceutical industry to qualify suppliers appropriately, according to current regulatory and legal requirements.
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