Muenster (Germany), 10 June 2008. The blue inspection body GmbH (www.blue-inspection.com) is the first inspection body for active pharmaceutical ingredients (API) in the European Union to be accredited with the highest level of independence, type A. The audit service provider operates worldwide on behalf of pharmaceutical companies to check whether API suppliers meet the requirements of Good Manufacturing Practice. Audits are considered an important means of improving the safety of medicinal products. Since 2006 they have been required for active pharmaceutical ingredients manufactured in other countries to be allowed to undergo further processing in Europe. It is estimated that almost 80% of all starting materials and excipients for medicinal products in the EU and the USA come from third countries.
blue inspection has been accredited by the DAP German Accreditation System for Testing in accordance with the international standard ISO/IEC 17020. The type A accreditation it has been awarded certifies that the company is a qualified and competent auditor – and that it is independent from the medicinal product manufacturer in Europe as well as from the API supplier that is to be inspected in, for example, India or China.
The importance of plant inspections for the safety of medicinal products is illustrated by the heparin scare in early 2008: at that time a Chinese active pharmaceutical ingredient supplier had supplied contaminated batches of heparin to medicinal product manufacturers worldwide. The result was more than 80 deaths in the USA alone. During investigations it emerged that the US medicinal products agency, the FDA, had not inspected the company as required because of a staff shortage. In Europe, the manufacturers of medicinal products are directly responsible for inspections of suppliers. For these they use, among others, specialized audit service providers such as blue inspection body GmbH.
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