Muenster (Germany), 11. March 2008. The audit service provider blue inspection body GmbH (www.blue-inspection.com) in Muenster, Germany, has strengthened its team of pharmaceutical inspectors by recruiting Dr. Wolfgang Heisig. blue, which operates internationally on behalf of the pharmaceutical industry, checks whether active pharmaceutical ingredient manufacturers meet the requirements of Good Manufacturing Practice (GMP). Dr. Wolfgang Heisig is a pharmacist and has been Head of Quality Control and Qualified Person for over 15 years. He joined blue inspection body GmbH from special medicinal products manufacturer medac GmbH in February, taking up the position of chief GMP auditor.
Active pharmaceutical ingredients (API) and certain excipients that are to be made into medicinal products in Europe must meet the requirements of the EU GMP guidelines. Drug manufacturers must regularly carry out on-site audits to ensure that these requirements are being met by the supplier plants, e.g. in China or India. This task is undertaken by specialist service providers such as blue inspection body GmbH. The audit criteria are set specifically for each medicinal product and each active substance based on the terms of marketing authorisation dossiers – this task, too, will in future be undertaken by Dr. Wolfgang Heisig for blue inspection body GmbH.
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