Oct. 21, 2008
-- The German audit service provider blue inspection body GmbH has just released a Chinese version of its new web site www.blue-inspection.com. "Since the majority of our auditees is located in Asia – with most of them in China – the release of our web site in a local language is a matter of course.“ explains Dr. Stefan Kettelhoit, the managing director. The blue inspection body GmbH is the first accredited audit service provider (type A) for active pharmaceutical ingredients (APIs). The company conducts GMP audits of API suppliers on behalf of pharmaceutical manufacturers and marketing authorisation holders.
Natural or legal persons manufacturing or selling medicinal products in Europe have to provide evidence of their compliance with all relevant legal and regulatory requirements. This not only applies to final medicinal products but also to APIs and excipients used in the manufacturing process. The inspection of these legal requirements is performed on appointment by blue inspection body GmbH. The company conducts independent audits of the GMP compliance of API manufacturers and suppliers around the globe.
Besides Chinese, www.blue-inspection.com is also available in English and German.
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The blue inspection body GmbH is the first accredited inspection body for active pharmaceutical ingredients (APIs) in the European Union. Working on behalf of pharmaceutical industry, the auditors of blue operate worldwide to audit that suppliers are operating in accordance with the rules of good manufacturing practice (GMP) for active pharmaceutical ingredients. In the year 2008 blue has been accredited by the Deutsche Akkreditierungssystem Prüfwesen with the highest level of independence (ISO/IEC 17020, type A) for the "inspection of excipient and active pharmaceutical ingredient manufacturers for pharmaceutical products and determination of the conformance with international GMP rules".