Muenster (Germany), 16 March 2012. The first accredited Good Manufacturing Practice (GMP) inspection body in Europe broadens its range of services: blue inspection body (www.blue-inspection.com) successfully completed an audit of an antibody manufacturing site for a Russian pharmaceutical company. The contract giver, OOO NPF MATERIA MEDICA HOLDING, uses the Biotech-derived glycoprotein for manufacturing homoeopathic medicinal products supplied to the Russian market.
Pharmaceutical manufacturers must verify compliance with GMP standards along the entire manufacturing and supply chain, including the active pharmaceutical ingredients (APIs) used in their products. „For Biotech-derived APIs the quality standards are particularly high“, underlines Yulia Demidchenko of MATERIA MEDICA HOLDING. This holds especially true for substances such as rabbit polyclonal antibodies. „Therefore we decided to commission an independent third party, namely blue inspection body GmbH, with auditing the GMP compliance of our manufacturer“, states Demidchenko.
Blue inspection body GmbH is the first independent service provider specifically accredited for GMP audits of API manufacturers in the European Union. Since 2008 the inspectors of blue completed audits of more than 150 APIs related to about 100 production sites in Europe, Asia, North and South America, Australia and Africa.
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